"Efesovir" (FS-1) for COVID-19, Phase 2

• Status: Not yet recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Study of the efficacy and safety of the new drug "Efesovir" in comparison with the drug "Remdesivir" in the treatment of patients hospitalized with COVID-19.

The hypothesis of clinical study is the clinical efficacy of new drug "Efesovir" is 10% to 30% higher than of "Remdesivir".

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Scientific Center for Anti-infectious Drugs, Kazakhstan

Criteria

Inclusion Criteria:

• polymerase chain reaction (PCR) confirmed coronavirus infection (COVID-19) in hospitalized patients with severe risk factors in age from 18 years to 59 years, of both sexes, irrespective of national or ethnic origin

• the duration of the COVID-19 disease is no more than 10 days

• informed concent to participate in clinical trials

• informed concent to to use reliable contraceptive methods while participating in a clinical trial

Exclusion Criteria:

• age less than 18 years old and over 59 years old

• pregnancy or breastfeeding

• hypersensitivity, allergy, intolerance to iodine, iodine-containing medicines

• hypersensitivity to Remdesivir or its components

• impaired consciousness, causing the impossibility of oral administration

• conditions or circumstances that, in the opinion of the investigator, may affect the patient's safety or the quality of the results obtained

• participation in another clinical trial, including in the period up to 2 months before this study

• signs of multiple organ failure

• alanine aminotransferase (ALT), aspartate aminotransferase (AST) is 5 or more times higher than normal

• thrombocytopenia below 100 * 10^9/ l

• decrease in glomerular filtration rate (GFR) less than 30 ml / min by 1.73 m2

• chronic heart failure with reduced ejection fraction

• liver failure

• coagulopathy

• mechanical ventilation for 48 hours or more

• extracorporeal membrane oxygenation (ECMO)

• disseminated intravascular coagulation