Phase IIa Study of Codivir Versus Placebo for Treatment of Moderate COVID-19 in Hospitalized Adults

What this Trial Is About

Researchers are evaluating the safety and initial effectiveness of the drug Codivir in adults hospitalized with moderate COVID-19 symptoms. The study involves 130 patients whose symptoms have started within 7 days before enrolling. This phase IIa, double-blind, randomized placebo-controlled trial is conducted across multiple centers and countries to better understand how Codivir may impact COVID-19 recovery. Participants receive either Codivir or a placebo, administered as a 20 mg subcutaneous injection twice daily for 7 days. Treatment begins in the hospital, and if medically appropriate, patients continue treatment at home with nurse visits twice daily until Day 7. After treatment, participants are followed up by telephone up to Day 28 to monitor health, collect information on symptoms and any side effects, and provide guidance. During the study, participants undergo various assessments including physical exams, electrocardiograms, blood tests, and symptom scoring. Researchers track changes in the World Health Organization Ordinal Scale for clinical improvement up to 28 days, as well as COVID-19 symptom scores, viral load, antibody levels, and any adverse events. Safety and health status are monitored throughout the study, with medical decisions guiding continued treatment or hospitalization as needed.

Phase IIa Randomized Placebo Controlled Clinical Study of Codivir in Hospitalized Patients with Moderate COVID-19