PIII NCT04292730 (n=596) is published; it reported day 11 clinical status distribution was significantly better for 5-day course of remdesivir vs standard care (OR, 1.65; 95% CI, 1.09-2.48; P = 0.02) but not for 10-day course vs standard care (P = 0.18). The clinical importance of these findings are uncertain .
Further data announced from PIII SIMPLE-severe trial and a retrospective cohort study of patients with severe Covid-19. Claims of improved clinical recovery (74.4% of remdesivir patients by day 14 compared to 59% of standard of care patients) and 62% reduction in risk of death compared to standard of care (day 14 mortality rate reduced from 12.5% [standard of care] to 7.6% [remdesivir]. These findings need to be confirmed in clinical trials. Subgroup analyses of PIII trial results looked at safety and efficacy in a range of different ethnic groups; similar results to the overall patient population were reported. Data from the compassionate use scheme report that 83% of paediatric patients recovered by day 28, and 92% of pregnant and postpartum women recovered by day 28. No new safety issued observed. .
A PII/III, open-label single-arm trial (NCT04431453) of remdesivir will soon start enrolling 50 paediatric patients with moderate-to-severe COVID-19. There will be more than 30 sites across the US and Europe. Safety and efficacy will be assessed .
PIII ADAPTIVE COVID-19 treatment trial 2 (ACTT-II; NCT04401579) started recruitment. The study is a multicenter trial that will be conducted in up to approximately 100 sites globally. The study will compare different investigational therapeutic agents to a control arm. New arms can be introduced according to scientific and public health needs. There will be interim monitoring to allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). ACTT-II will evaluate the combination of baricitinib and remdesivir compared to remdesivir alone. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. The primary outcome is time to recovery by Day 29. A key secondary outcome evaluates treatment-related improvements in the 8-point ordinal scale at Day 15. Estimated primary completion date is Aug 2023 .
Further data announced from the PIII SIMPLE trial which demonstrated that pts in the 5-day remdesivir gp were more likely to have clinical improvement at Day 11 vs. the standard of care group (OR 1.65 [95% CI 1.09-2.48]; p=0.017). The odds of improvement in clinical status with 10-days of remdesivir vs. standard of care were favorable but not statistically significant (OR 1.31 [95% CI 0.88-1.95]; p=0.18). No new safety signals were identified with remdesivir but safety may potentially have contributed to overall outcomes. Gilead plans to submit the full data for publication in a peer-reviewed journal in the coming weeks and they plan to expand the study to add another 1,000 moderately ill pts .
Preliminary data from PIII ADAPTIVE trial (ACTT; NCT04280705) published in the NEJM .
Topline results announced from from the open-label, uncontrolled, PIII SIMPLE trial of remdesivir in pts with severe COVID-19 (with pneumonia and reduced oxygen levels but not requiring mechanical ventilation). Pts receiving a 10-day course of remdesivir achieved similar improvement in clinical status vs. a 5-day course (OR: 0.75 [95% CI 0.51 – 1.12] on Day 14). Time to clinical improvement for 50% of pts was 10 days in the 5-day gp and 11 days in the 10-day gp. At Day 14, 64.5% of pts in the 5-day group and 53.8% of pts in the 10-day group achieved clinical recovery (defined as no longer requiring oxygen support and medical care or discharge from hospital). Investigators suggested that pts who received treatment earlier responded better. Clinical outcomes varied by geography. Outside of Italy, the overall mortality rate at day 14 was 7% across both treatment groups. No new safety issues were observed .
A preliminary data analysis from the randomised, controlled PIII ADAPTIVE COVID-19 treatment trial (ACTT; NCT04280705; n=1063), run by the US National Institutes of Allergy and Infectious Diseases (NIAID), indicate that the median time to recovery was 11 days for pts treated with remdesivir vs. 15 days for those who received placebo (p<0.001). Results also suggested a survival benefit, with a mortality rate of 8% for pts receiving remdesivir vs. 11.6% for the placebo group (p=0.059). The study is being carried out at multiple sites worldwide, including the US, Europe and the UK [15-17].
A snapshot of data from patients (n=61) hospitalised with Covid-19 who received remdesivir on a compassionate-use basis has been published in the NEJM 
Gilead has made major mid-study changes to two PIII open-label, randomised global trials to assess the antiviral activity and safety of remdesivir vs standard of care treatment in patients with severe (NCT04292899) or moderate (NCT04292730) COVID-19, quadrupling the enrolment target (n=7,600 in total) and changing the primary endpoints to focus on the odds of improvement over 14 days on a seven-point scale that runs from death to not hospitalised [12,13].
Gilead stop two trials in China due to "The epidemic of COVID-19 has been controlled well in China, no eligible patients can be enrolled at present." These are, a PIII trial (NCT04252664) of remdesivir in pts with mild and moderate COVID-19 and a PIII trial(NCT04257656) in pts with severe Covid. 
Gilead has initiated two PIII randomised studies to evaluate the safety and efficacy of its investigational treatment remdesivir in patients with moderate to severe COVID-19 (coronavirus). The two studies which have been given urgent public health research (UPHR) status by the Chief Medical Office will initially involve 15 centres* in the UK .
The World Health Organization (WHO) is putting together a multi-nation trial (SOLIDARITY) to speed up research on coronavirus treatments. It aims to generate data that can be used to determine which treatments are most effective, if they reduce mortality and time spent in the hospital, and if any pts receiving the drugs require ventilation or admission to an ICU. The trial’s design allows more drugs to be added as they become available at participating hospitals. It will consist of 5 arms: 1. standard of care, 2. remdesivir, 3. Kaletra, 4. Kaletra plus interferon beta, 5. chloraquine. Ten countries have already confirmed that they will participate in the trial: Argentina, Bahrain, Canada, France, Iran, Norway, South Africa, Spain, Switzerland and Thailand. 
A randomized, placebo controlled trial to evaluate the safety and efficacy of remdesivir in hospitalized adults diagnosed with coronavirus disease 2019 (COVID-19) has begun at the University of Nebraska Medical Center (UNMC) in Omaha, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Participants must have laboratory-confirmed SARS-CoV-2 infection and evidence of lung involvement, including rattling sounds when breathing (rales) with a need for supplemental oxygen or abnormal chest X-rays, or illness requiring mechanical ventilation. Patients will be scored daily and investigators will compare participant outcomes on day 15 in both the remdesivir group and the placebo group. Data will be reviewed after the first 100 participants .
The first of two PIII randomised double-blind placebo-controlled trials (NCT04257656) has begun recruitment in China to investigate efficacy and safety of remdesivir in patients (n=452 planned) with severe 2019-nCoV respiratory disease. Primary outcome is time to clinical improvement defined as the time (in days) from initiation of study treatment (active or placebo) until a decline of two categories from admission status on a six-category ordinal scale of clinical status which ranges from 1 (discharged) to 6 (death). The other study (NCT04252664) will investigate the treatment in patients (n=308 planned) with mild-moderate disease. Primary outcome measure is time to clinical recovery defined as the time (in hours) from initiation of study treatment (active or placebo) until normalisation of fever, respiratory rate, and oxygen saturation, and alleviation of cough, sustained for at least 72 hours. Patients in both trials will be followed for 28 days with estimated primary completion dates in Apr 20 [3,5].