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12th May 2022
Cancer patients with COVID-19 have been found to be at a greater risk of hospitalisation and 30-day all-cause mortality compared to those without the disease according to the results of a study by a US team from Texas.
The presence of cancer has become a recognised factor that is associated with a higher risk for severe outcomes in those infected with COVID-19 and which is largely due to the presence of a compromised immune system.
During the early course of the pandemic, studies observed that a higher proportion of cancer patients infected with COVID-19 were both hospitalised and subsequently died, compared to those without the disease. In contrast, however, other studies have suggested that cancer and non-cancer patients have comparable COVID-19 outcomes after adjusting for age, sex, and comorbidity.
Furthermore, the impact of factors such as cancer treatments, different cancer types on COVID-19 related outcomes has been less well studied.
For the present study, the US researchers examined the association between cancer-specific characteristics and COVID-19 outcomes. They turned to the Optum de-identified COVID-19 electronic health record, which is derived from over 700 hospitals and 7000 clinics across the USA. Using these data, the researchers examined the outcome of those with a laboratory confirmed COVID-19 and a recorded cancer diagnosis.
The primary objective was to determine the effect of cancer on COVID-19 outcomes including 30-day all-cause mortality, hospitalisation, intensive care unit (ICU) admission and ventilator use. These outcomes were also analysed by the nature and type of cancer in comparison to patients without cancer.
The authors the explored if there were any other specific factors in those with cancer which impacted on COVID-19 outcomes.
Cancer patient with COVID-19 and related outcomes
A total of 271,639 patients with confirmed COVID-19 of whom 18,460, with a mean age of 66 years (45.3% male) had a cancer diagnosis were analysed. Among those with cancer, 8034 patients had a history of cancer for longer than 12 months and 10,426 had a more recent diagnosis, i.e., within 1 year before COVID-19.
30-day all-cause mortality was more than three times higher among those with cancer (6.8% vs 1.9%) compared to non-cancer patients. After adjustment for age, sex, ethnicity and risk factors, the presence of cancer was associated with a 7% higher risk of death (relative risk, RR = 1.07, 95% CI 1.01 – 1.14, p = 0.028) compared to those without the disease.
Similarly, there was a 4% higher risk of hospitalisation (RR = 1.04, 95% CI 1.01 – 1.07, p = 0.006). When comparing the duration of cancer, those with a recent diagnosis had both a significant (p < 0.001) increased risk of mortality (RR = 1.17) and hospitalisation (RR = 1.10) although this risk was non-significant for those who had cancer for much longer.
There was also an increased mortality risk for those with recent metastatic (RR = 2.09), solid tumour (RR = 1.12) and haematological (RR = 1.48) cancers compared with those without the disease. Individual cancers with a significantly elevated risk were leukaemia (RR = 1.58), liver (RR = 2.46), lung (RR = 1.85) and pancreatic (RR = 1.94).
When exploring the factors related to COVID-19 mortality in those with recent cancer, both chemotherapy (RR = 1.37) and radiotherapy (RR = 1.83) within 3-months before COVID-19, were significantly associated with a higher risk of death as was increasing age (i.e., > 75 years) (RR = 6.69).
In addition, the only significant co-morbidities were cardiovascular disease (RR = 1.72), diabetes (RR = 1.39) and renal disease (RR = 1.51).
Citation
Kim Y et al. Characterizing cancer and COVID-19 outcomes using electronic health records PLoS One 2022
13th April 2022
COVID-19 vaccinated cancer patients have been found to be at a higher risk of breakthrough infections and which are associated with a substantial risk of hospitalisation and mortality. This was the conclusion of a retrospective cohort study of electronic health records by a team from the Center for Artificial Intelligence in Drug Discovery, Case Western Reserve University, Ohio, US.
Patients with cancer have been found to be at a significantly increased risk for COVID-19 infection and worse outcomes though fortunately, COVID-19 vaccination has been shown to be associated with lower infection rates in cancer patients.
However, despite vaccination, the occurrence of breakthrough infections has also been reported and this appears to be correlated with neutralising antibody titers during the peri-infection period.
While COVID-19 vaccinated cancer patients are also potentially likely to experience breakthrough infections, there is a lack of data on the extent to which such breakthrough infections occur among those with cancer and how, or if, this might be influenced by the different cancer sites.
For the present study, the US team turned to the TriNetX database which contains de-identified information on 90 million patients in the US. The team looked for vaccinated patients with one of 12 different cancers including pancreatic, liver, lung, colorectal, skin and thyroid and compared the level of breakthrough infections with a group of vaccinated, patients without any of the specified cancers.
Data on age, sex, race and co-morbidities were collected for all patients and adjusted for in the analysis. The researchers examined the monthly incidence of breakthrough infections between December 2020 and November 2021 as well as the risk of hospitalisation and death among those infected.
COVID-19 vaccinated cancer patients and breakthrough infections
A total of 45,253 vaccinated cancer patients with a mean age of 68.7 years (53.5% female) were included in the analysis and matched with 591,212 vaccinated, non-cancer patients.
The cumulative risk of a breakthrough infection during the period of study among vaccinated COVID-19 cancer patients, was 13.6% which was higher than vaccinated, non-cancer patients, (Hazard ratio, HR = 1.24, 95% CI 1.19 – 1.29). Among the different cancer sites, the highest risk was for patients with pancreatic cancer (24.7%), followed by liver (22.8%), lung (20.4%) and colorectal (17.5%).
The only cancer not associated with a significant increased risk for a breakthrough infection was thyroid (HR = 1.07, 95% CI 0.88 – 1.30) although the increased risk among patients with skin cancer was of borderline significance (HR = 1.17, 95% CI 0.99 – 1.38).
The risk of hospitalisation among cancer patients with breakthrough infections was much higher than matched, non-cancer patients (31.6% vs 3.9%, HR = 13.48). In addition, mortality risks were also significantly elevated (HR = 6.76, 95% CI 4.97 – 9.20).
The authors concluded that their results emphasised the need for those with cancer to maintain mitigation practices, especially given the emergence of COVID-19 variants for which vaccination might not provide full protection.
Citation
Wang W et al. Breakthrough SARS-CoV-2 Infections, Hospitalizations, and Mortality in Vaccinated Patients With Cancer in the US Between December 2020 and November 2021 JAMA Oncol 2022
4th April 2022
The results of a large RCT have shown that early ivermectin use in patients who are symptomatic with COVID-19 does not reduce either hospitalisation or emergency department (ED) visits due to a worsening of the disease compared to placebo.
The TOGETHER trial was designed to examine the potential value of several repurposed drugs for the management of COVID-19 including fluvoxamine, metformin and ivermectin and conducted by researchers from Brazil although the present study only describes the use of ivermectin.
In 2020 an in vitro study reported that the anti-parasitic, drug ivermectin, was able to inhibit COVID-19 leading to an approximate 5000-fold reduction in viral RNA after 48 hours. As a result, several clinical studies were initiated and a review of the emerging evidence in 2021 concluded that meta-analyses based on 18 randomised trials of ivermectin in COVID-19 have found large, statistically significant reductions in mortality, time to clinical recovery, and time to viral clearance.
Furthermore, the authors added how results from numerous controlled prophylaxis trials report significantly reduced risks of contracting COVID-19 with the regular use of ivermectin. However, a later meta-analysis virtually reversed the earlier conclusions, finding that ivermectin did not show a statistically significant effect on survival or hospitalisations and no significant effect of ivermectin on time to clinical recovery.
Interestingly, the authors later retracted their analysis and in February 2022, they described how in their original analysis, many of the included studies were at a high risk of bias and that others were later identified to be potentially fraudulent.
In their 2022 article, they concluded that ‘failure to recognise the potentially fraudulent studies, which led to multiple meta-analyses suggesting significant benefits of ivermectin for COVID-19, indicates that the tools currently used to evaluate the quality of clinical trials are insufficient.’
In order to provide more definitive evidence, the Brazilian team randomised adult patients with symptoms suggestive of COVID-19 (for no longer than seven days), on a 1:1 basis, to ivermectin use (400 microgram/kg body weight) once daily for three days or matching placebo. In addition, all participants had at least one risk factor for disease progression.
The primary outcome was a composite of hospitalisation due to COVID-19 within 28 days of randomisation or an emergency department visit because of worsening symptoms (defined as remaining under observation for > 6 hours) also within 28 days of randomisation.
Secondary outcomes included COVID-19 viral clearance at days 3 and 7, time to hospitalisation and time to clinical recovery.
Ivermectin use and COVID-19 outcomes
A total of 1358 patients with a median age of 49 years (58.2% women) were randomised to either ivermectin (679) or placebo. Risk factors for disease progression included cardiovascular disease, uncontrolled hypertension, COPD, asthma, type 1 diabetes and chronic kidney disease.
In total, 14.7% of those assigned to ivermectin use met the primary outcome compared to 16.3% in the placebo arm (relative risk, RR = 0.90, 95% CI 0.70 – 1.16). There were a total of 211 primary outcome events, of which 81% were hospital admissions. Moreover, there were no significant differences for any of the secondary outcomes.
Based on these findings, the authors concluded that ivermectin use had no significant impact on preventing disease progression or prolonged emergency department observations.
Citation
Reis G et al. Effect of Early Treatment with Ivermectin among Patients with Covid-19 N Engl J Med 2022
29th March 2022
Individuals who become infected with the Omicron COVID-19 variant experience less severe outcomes such as hospitalisation and death compared to those with the Delta variant according to the results of a large study by a multi-disciplinary group of UK researchers.
The Omicron COVID-19 variant has produced a surge of infections and been found to be associated with high transmission among household contacts, particularly among those who lived with index patients who were not vaccinated or who did not take measures to reduce the risk of transmission to household contacts.
Nevertheless, despite a higher level of transmissibility, studies have also suggested that the Omicron variant is associated with substantial severity of illness in comparison to the Delta variant.
With an increasing number of individuals now fully vaccinated against COVID-19, the purpose of the present study was to offer a more detailed understanding of the overall impact of both less severe outcomes and greater immunity on rates of hospitalisation and mortality during the Omicron wave.
The UK team obtained individual-level data on confirmed cases of COVID-19 infection in England between November 2021 and 9 January 2022 and linked these to vaccination status, hospital attendance and admission as well as deaths.
During the period of study genomic sequencing was performed for some of the infections which enabled the team to distinguish between the two variants. For the study, a hospital admission was defined as a stay of at least one or more days. The analysis was stratified by age, vaccination status and adjusted for sex, deprivation index and evidence of prior infection.
Omicron caused less severe outcomes
During the period of study there were 4,135,347 confirmed cases of COVID-19, of which 1,526,702 (37%) had information on the infecting variant and consisted of 448,843 Delta and 1,067,859 Omicron cases.
The adjusted hazard ratio (HR) for attendance at hospital, but not necessarily admission, was lower for Omicron than Delta (HR = 0.56, 95% CI 0.54 – 0.58). In addition, compared to Delta, the risk of hospital admission among those infected with Omicron was 59% lower (HR = 0.41, 95% CI 0.39 – 0.43) and the risk of death within 28 days was 69% lower (HR = 0.31, 95% CI 0.26 – 0.37).
When stratified by age, there was no difference between the two variants among those 10 years of age and younger (HR = 1.10, 95% CI 0.85 – 1.42). However, there was a significant difference and reduction among those at least 80 years of age (HR = 0.47, 95% CI 0.40 – 0.56).
For both of the variants, prior infection offered protected against death in those who were vaccinated (HR = 0.47) and unvaccinated (HR = 0.18). Interestingly, among those who were vaccinated, prior infection appeared to offer no additional protection against infection (HR = 0.96, 95% CI 0.88 – 1.04), which was in contrast to those who were unvaccinated but had a previous infection (HR = 0.55, 95% CI 0.48 – 0.63).
The authors concluded that the less severe outcomes observed for Omicron were largely driven by a less severe variant and increased immunity due to vaccination.
Citation
Nyberg T et al. Comparative analysis of the risks of hospitalisation and death associated with SARS-CoV-2 omicron (B.1.1.529) and delta (B.1.617.2) variants in England: a cohort study Lancet 2022
7th February 2022
Vitamin D-deficient individuals have been shown to be much more likely to experience severe COVID-19 and die in comparison to those with normal or sufficient levels of the vitamin. This was an important finding by researchers from the Department of Otolaryngology, Head and Neck Surgery, Galilee Medical Center, Israel.
Previous research has shown how vitamin D has a protective effect against respiratory tract infections when taken as a once daily dosage. Moreover, a 2021 systematic review which included 46 randomised controlled trials with 48,488 individuals, re-affirmed the benefits of daily supplementation with 400 –1000 IU of vitamin D for reducing the risk of acute respiratory tract infections compared with placebo.
Several studies undertaken during the COVID-19 pandemic have suggested that a vitamin D deficient status was associated with increased COVID-19 risk.
Furthermore, other data has shown how the vitamin D level is markedly low in severe COVID-19 patients although this was measured once in hospital. However, what is less clear, is the extent to which pre-infection or baseline vitamin D levels, impact on the clinical outcomes once patients become infected with COVID-19.
For the present study, the Israeli team set out to determine whether COVID-19 disease severity correlated with patient’s most recent vitamin D levels as documented in their medical records. They undertook a retrospective study of hospitalised, adult patients with a PCR-confirmed COVID-19 infection.
The team defined COVID-19 disease severity at the point of highest severity. For instance, if a patient was admitted with mild disease and which subsequently deteriorated, this would be categorised as a critical illness.
They used the most recent medical record for vitamin D status and then categorised patients as vitamin D deficient (< 20 ng/ml), insufficient (20 – 29.9 ng/ml), adequate (30 – 39.9 ng/ml) and high-normal (40 ng/ml). They used multivariable analysis to examine the relationship between vitamin D status and COVID-19 disease severity.
Vitamin D deficient status and COVID-19 severity
A total of 253 individuals with a mean age of 63.3 years (56.9% female) were included in the analysis. Among the cohort, 52.5% were vitamin D-deficient, 14.2% had levels between 20 and 30ng/ml and 15.8% had a level of 40ng/ml or above.
Mortality from COVID-19 occurred in 2.3% of those with adequate vitamin D levels and 25.6% of individuals who were vitamin D deficient (p < 0.001). When stratifying COVID-19 disease severity with vitamin D status, among those with the lowest vitamin D levels, a higher proportion (87.4%) developed severe or critical COVID-19 compared to mild to moderate disease, 34.3% (p < 0.001).
In regression analysis, patients with vitamin D deficiency compared to those with high-normal levels (40 ng/ml) were 14 times more likely to develop severe or critical illness (odds ratio, OR = 14, 95% CI 4 – 51, p < 0.001). Overall, when comparing pre-hospital vitamin D levels with COVID-19 disease severity, there was a clear inverse relationship such that as vitamin D levels reduced, COVID-19 disease severity increased.
Further analysis revealed that age was an independent risk factor for more severe disease and the strongest correlation between vitamin D status and COVID-19 severity occurred in those aged 50 years and over (r = – 0.74, p < 0.001). However, this correlation was still significant among those under 50 years of age (r = -0.66, p < 0.001).
The authors described how early on in the current pandemic, there was much debate on the role of vitamin D in protecting against COVID-19. They suggested that their study provided further evidence of how vitamin D deficient patients were at a much higher risk of more severe COVID-19 infection and called for further studies to investigate if and when vitamin D supplementing in those who are deficient, impacts on COVID-19-related outcomes.
Citation
Dror AA et al. Pre-infection 25-hydroxyvitamin D3 levels and association with severity of COVID-19 illness PloS One 2022
24th December 2021
According to a preprint study by researchers from the Centre for Respiratory Diseases and Meningitis, Johannesburg, South Africa, Omicron infections appear to be associated with reduced risk of hospitalisation and after admission, less severe disease than the Delta variant.
While the Omicron COVID-19 variant was only identified in November 2021, there has been a flurry of research activity directed at trying to understand its transmissibility, the level of disease severity and effect on healthcare services. While initial laboratory studies have indicated that the variant can escape neutralisation by antibodies generated in fully vaccinated and boosted sera samples, these studies cannot foretell the clinical impact of the variant.
The South African researchers undertook a data linkage study of COVID-19 infections, case data and genomic information to establish whether an Omicron infection was associated with higher rates of hospitalisation and more severe disease among those who were hospitalised in comparison to the Delta COVID-19 variant. Although whole genome sequencing was not used, they utilised the presence of a S Gene Target Failure (SGTF), which serves as a proxy for Omicron and samples were examined between 1st October 2021 and 6th December 2021. Positive infections were therefore classified as either an SGTF or non-SGTF. The severity of an Omicron infection was assessed by comparison of SGTF and non-SGTF infections and to infections known to be caused by the Delta variant and regression models created and adjusted for several factors known to be associated with hospitalisation (e.g., age, sex, co-morbidities).
Findings
During the period of study there were 161,328 COVID-19 cases recorded and the proportion of SGTFs increased from 3% (early October 2021) to 98% (early December).
A total of 11,495 hospital admissions occurred with 2.5% due to an SGTF compared to 12.8% with a non-SGTF (p < 0.001). Multivariate analysis revealed that individuals with a SGTF had a lower odds of hospitalisation (adjusted odds ratio, aOR = 0.2, 95% CI 0.1 – 0.3, p < 0.001). In addition, once hospitalised, the odds of having severe disease were also reduced in those with SGTF although there was uncertainty over this estimate given the wide confidence intervals (aOR = 0.70, 95% CI 0.30 – 1.40).
Finally, the researchers found that compared to infection with the Delta variant, those with an SGTF had a significantly lower risk of severe disease (aOR = 0.30, 95% CI 0.20 – 0.50, p < 0.001).
The authors suggested that these data suggested that an Omicron infection was probably less severe than other variants such as Delta but recognised that this reduced severity might be accounted for by the higher levels of population immunity due to either natural infection and/or vaccination.
These results are broadly similar to those of a second recently published preprint from Scotland which found a nearly 70% reduced risk of hospitalisation (expected ratio = 0.32, 95% CI 0.19 – 0.52) for those with an Omicron infection. The study also found that giving a third or booster dose was associated with a 57% reduced risk of symptomatic infection.
Although both studies are preliminary, they do suggest the possibility that infection with the new variant is potentially less severe than other forms.
Citation
Wolter N et al. Early assessment of the clinical severity of the SARS-CoV-2 Omicron variant in South Africa. MedRxiv 2021
13th December 2021
Active disease in leukaemia patients gives rise to more severe disease after infection with COVID-19 and a higher incidence of mortality, but only where individuals are neutropenic or of their pre-COVID-19 prognosis was under 6 months. This was the finding of a retrospective analysis by researchers based at the Division of Haematology and Oncology, Weill Cornell Medical College, New York, US, presented at ASH 2021.
The most important predictors of both a severe infection and related outcomes after infection with COVID-19 in patients acute leukemias including with acute myeloid leukaemia (AML), acute lymphocytic leukaemia (ALL) and myelodysplastic syndromes (MDS) are uncertain. However, it is possible that active disease in leukaemia might result in more severe disease due to the presence of cytopenias. Data held in the American Society of Haematology ASH RC COVID-19 Registry, which was established on 1 April, 2020 for data collection and which is regularly updated, provides researchers with a rich source of data on the impact of COVID-19 among those with leukaemia. The registry includes patient characteristics such as age, comorbidities, type of haematological malignancy (AML, MDS, ALL), neutrophil and lymphocyte count and active treatments prescribed at the time of COVID-19 diagnosis as well as the outcomes associated with infection.
Using this registry data, the US team documented patient outcomes after infection with COVID-19 stratified by disease status (active initial diagnosis and relapsed/refractory vs. remission) and type of haematologic malignancy. COVID-19 severity was defined as mild (i.e., no hospitalisation required), moderate (hospitalisation required), or severe (ICU admission required). Categorical patient characteristics for each response group and associations between response groups and characteristics (i.e., alive vs. dead, severity vs. non-severity) were summarised by frequency and multivariable analyses used to identify independent predictors of outcomes.
Findings
Data were analysed for 257 patients with AML (n=135), MDS (n=40), and ALL (n=82) with 47% of patients aged less than 60years of age. At the time of infection, active disease in leukaemia was present in 44% of individuals and the overall mortality from COVID-19 infection was 21%. Those with active disease were significantly more likely to present with moderate and severe COVID-19 compared to those in remission when the data were dichotomised as severe vs. non severe and this difference was significant (p = 0.002).
Multivariable analyses revealed that for the whole cohort, increased COVID-19 related mortality was significantly associated only with neutropenia at diagnosis (odds ratio, OR = 3.15, 95% CI 1.31-8.08, p=0.01) and where the estimated pre-COVID-19 prognosis was under 6 months (OR = 8.58, 95% CI 3.24-24.46, p<0.001). However, a further factor appeared to be avoidance of intensive care (OR = 6.66, 95% CI 2.56-18.23, p<0.001).
Restricting the analysis to only hospitalised patients revealed how an increased COVID-19 mortality was again associated with estimated pre-COVID-19 prognosis of < 6 months (OR = 6.77, 95% CI 2.34-22.24, p<0.001) and in those forgoing ICU care (OR = 3.98, 95% CI 1.45-11.66, p = 0.007). Furthermore, mortality was not affected by the type of leukaemia.
The authors concluded that their data suggest that patients with active disease experience significantly higher COVID-19 severity but not increased mortality from COVID-19, apart from those with neutropenia and a pre-COVID-19 prognosis of < 6 months, for which mortality was higher, adding that if desired by patients, aggressive support for those hospitalised patients with COVID-19 is appropriate regardless of remission status.
Desai P et al. Clinical Predictors of Outcome in Adult Patients with Acute Leukemias and Myelodysplastic Syndrome and COVID-19 Infection: Report from the American Society of Hematology Research Collaborative (ASH RC) Data Hub. ASH Conference 2021
9th November 2021
Paxlovid given within three days of symptom onset to patients with COVID-19 significantly reduced the risk of hospitalisation and death. These were the results of an interim analysis posted by the manufacturer, Pfizer.
Paxlovid is a combination of Pfizer’s experimental drug (PF-00835231) and ritonavir. Both are protease inhibitors, a class of anti-viral drugs that have been used in the treatment of viral infections such as HIV and hepatitis C. COVID-19 produces a protease termed Mpro, which is vital to viral replication, and PF-00835231 been been found to be a potent inhibitor of Mpro. According to the manufacturer, co-administration of PF-00835231 and a low dose of ritonavir helps slow the metabolism of PF-07321332 so that it remains active for a longer period of time and at higher concentrations to help combat the virus.
Clinical study
In a clinical study, Paxlovid was used for the treatment of adults infected with COVID-19 but who, at the time of their illness, were not deemed sufficiently unwell to require hospitalisation but who were, however, considered to be at a higher risk of developing more severe illness. The study, Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients (EPIC-HR), is a randomised, 1:1, double-blind study, in which individuals received paxlovid or placebo orally every 12 hours for 5 days. The primary outcome of the study was the proportion of participants with COVID-19 related hospitalisation or death from any cause between days 1 and 28 after randomisation.
According to a pre-specified interim analysis based on 1219 participants, there was an 89% reduction in risk of COVID-19-related hospitalisation or death from any cause compared to placebo, in patients treated within three days of symptom onset. Overall, 3/389 (0.8%) who received paxlovid were hospitalised through to day 28 and there were no deaths but among 385 participants assigned to placebo, 27/395 (7.0%) were hospitalised and there were 7 deaths and this difference compared with Paxlovid was statistically significant (p < 0.0001).
Among patients treated within 5 days of symptom onset, 1.0% of those given Paxlovid were hospitalised through to day 28 (6/607) compared with 6.7% (41/612) of those given placebo (p < 0.0001). Moreover, to date, there have been no deaths were reported in patients receiving Paxlovid and 10 deaths in the placebo group.
Based on a recommendation of the independent data monitoring committee and after consultation with the FDA, Pfizer will cease further enrolment and submit the data for the FDA’s emergency use authorisation (EUA) as soon as possible.
Further trials with Paxlovid are on-going and the company will release these results in due course.
2nd November 2021
Giving fluvoxamine to patients with one or more risk factors for severe illness in COVID-19, reduced the proportion of patients requiring more than 6 hours of emergency care when administered within 7 days of symptom onset. This was the conclusion of a study from researchers based at the Department of Medicine, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, Brazil. Although vaccination against COVID-19 has become a priority across the globe, some work is continuing on the repurposing of existing medicines to treat the virus. One such drug is the antidepressant fluvoxamine which is an agonist for the sigma-1 receptor which is a chaperone protein at the endoplasmic reticulum with anti-inflammatory properties. In addition, a previous small trial in 152 patients with COVID-19, found that those given fluvoxamine had a lower likelihood of clinical deterioration over 15 days.
For the present study, researchers wanted to provide more robust evidence for the value of fluvoxamine in COVID-19. They performed a randomised, placebo-controlled trial among individuals who presented at an outpatient care setting with acute symptoms consistent with COVID-19 infection. All included patients had at least one additional risk factor for more severe illness e.g., diabetes, hypertension, symptomatic asthma etc., and a positive rapid antigen test for COVID-19. Individuals were then randomised 1:1 to receive fluvoxamine 100 mg twice daily for 10 days or matching placebo within 7 days of the onset of COVID-19 symptoms. The primary outcome was a composite endpoint of medical admission to a hospital setting due to COVID-19-related illness but who remained longer than 6 hours or who were hospitalisation due to progression of their illness within 28 days of randomisation. Several secondary outcomes were measured including hospitalisation for COVID-19, time to hospitalisation, number of days in hospital.
Findings
A total of 1497 patients with a mean age of 50 years (58% female) were randomised to either fluvoxamine or placebo. Overall, 180 patients assigned to fluvoxamine and 251 given placebo had any form of interaction with a COVID-19 emergency setting (relative risk, RR = 0.73, 95% CI 0.62 – 0.88). In the treatment group, 11% of participants compared with 16% in the placebo arm had the primary outcome event, of which 87% were hospitalisations, (RR = 0.69, 95% CI 0.53 – 0.90), giving a number needed to treat of 20 (i.e., 1/0.05).
There were no significant differences for any of the secondary outcomes, e.g., for hospitalisations ,the rates were 10% vs 13% (fluvoxamine vs placebo, p = 0.10). In addition, there 17 deaths in the treatment arm and 25 in the placebo group which was also non-significant.
The authors commented on how use of fluvoxamine for 10 days, was associated with a clinically important absolute risk reduction of the primary outcome. Furthermore, a limitation was the the study was undertaken before the more widespread availability of COVID-19 vaccines hence it remains unclear as to the effectiveness of fluvoxamine in those who have been vaccinated.
Citation
Reis G et al. Effect of early treatment with fluvoxamine on risk of emergency care and hospitalisation among patients with COVID-19: the TOGETHER randomised, platform clinical trial. Lancet Glob Health 2021
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