Table 1.
Summary of Some Relevant Registered Clinical Studies of New Oral Antivirals Against SARS‐Cov‐2
| Project/Study Title | Study Type | Country | Purpose | Status | Registration Database |
|---|---|---|---|---|---|
| EPIC‐HR: Study of Oral PF‐07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID‐19 | Interventional (clinical trial) | United States | This study aims to determine whether PF‐07321332/ritonavir is safe and effective for the treatment of adults who are ill with COVID‐19 and do not need to be in a hospital, but are at an increased risk of developing severe illness. The total study duration is up to 24 weeks. | Completed | ClinicalTrials.gov (NCT04960202) |
| Efficacy and Safety of Molnupiravir (MK‐4482) in Non‐Hospitalized Adult Participants With COVID‐19 (MK‐4482‐002) | Interventional (clinical trial) | United States | This study aims to evaluate the safety, tolerability, and efficacy of molnupiravir (MK‐4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to placebo as assessed by the percentage of participants who are hospitalized and/or die through day 29. | Completed | ClinicalTrials.gov (NCT04575597) |
| Platform Adaptive Trial of Novel Antivirals for Early Treatment of COVID‐19 in the Community (PANORAMIC) | Interventional (clinical trial) | United Kingdom | This study aims to find new treatments that help those suffering with COVID‐19 at home and in the community get better quicker and without needing to be treated in a hospital. | Recruiting | Not registered, although approved by the UK Medicines and Health Care Products Regulatory Agency and the Health Research Authority |
| COVID‐19 International Drug Pregnancy Registry (COVID‐PR) | Observational (prospective cohort study) | United States | This study aims to evaluate obstetric, neonatal, and infant outcomes among women treated with monoclonal antibodies or antiviral drugs indicated for mild, moderate, or severe COVID‐19 from the first day of the last menstrual period (LMP) to the end of pregnancy. For monoclonal antibodies, the exposure period also includes 90 days prior to the first day of the LMP. | Recruiting |
ClinicalTrials.gov (NCT05013632) EUPAS42517 |
| TURN‐COVID Biobank: The Dutch Cohort Study for the Evaluation of the Use of Neutralizing Monoclonal Antibodies and Other Antiviral Agents Against SARS‐CoV‐2 (TURN‐COVID) | Observational (prospective cohort study) | Amsterdam | This study aims to establish a prospective cohort together with a biobank of patients treated with new SARS‐CoV‐2 therapies to evaluate their real‐world effect and safety. | Recruiting | ClinicalTrials.gov (NCT05195060) |
| Postmarketing Surveillance Study of the Effectiveness and Safety of New Oral Antivirals for Outpatients With Mild‐Moderate COVID‐19 (ESOA‐19) | Observational (prospective cohort study) | Portugal | This study aims to record the demographic and clinical history of adult individuals receiving oral antivirals against COVID‐19 (nirmatrelvir/ritonavir and molnupiravir), providing real‐world data on the effectiveness and safety of such therapies, as well as serving for as the starting point for collaborative clinical studies, enabling their planning and execution. The study is set up as a cohort event monitoring for 3 months after onset treatment and will be implemented in hospitals and primary health care centers. | Recruiting | EUPAS48186 |