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Antiviral Agents Against COVID-19 Infection

NCT04468087 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2024-03-22

No results posted yet for this study

Summary

A key strategy in the treatment of COVID-19 would be to find an effective antiviral agent that would decrease the peak viral load and, consequently, the associated degree of immunopathological damage that follows this phase. The clinically approved substances considered for this study are used for treatment of other virus diseases, like HIV (atazanavir) and HCV (sofosbuvir and daclatasvir). Severe progression of COVID-19 among patients under treatment for these aforementioned viruses is empirical less common. Besides, the clinical rationale, there are pre-clinical evidence pointing out that patients with COVID-19 could benefit from treatments with atazanavir, sofosbuvir and daclatasvir.

Conditions

Interventions

DRUG

Atazanavir

600 mg (2 capsules) twice daily on the first day and 300 mg (1 capsule) twice daily for the subsequent 9 days.

DRUG

Daclatasvir 60 mg

initial dose of 120mg (2 capsules), followed by 60mg (1 capsule) once daily for 9 days.

DRUG

Sofusbuvir + Daclastavir 60 mg

400 mg twice daily (2 capsules) on the first day and 400 mg (1 capsules) once daily for the subsequent 9 days (sofusbuvir) + initial dose of 120mg (2 capsules), followed by 60mg (1 capsule) once a day for 9 days (daclastavir)

DRUG

Placebo Atazanavir

2 capsules twice daily on the first day and 1 capsule twice daily for the subsequent 9 days.

DRUG

Placebo Daclatasvir 60 mg

2 capsules twice daily on the first day and 1 capsule twice daily for the subsequent 9 days.

DRUG

Placebo Sofusbuvir + Daclatasvir 60 mg

2 capsules twice daily on the first day and 1 capsule twice daily for the subsequent 9 days.

Sponsors & Collaborators

  • Hospital do Coracao

    lead OTHER

Principal Investigators

  • Israel S Maia, MSc · HCor Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-15
Primary Completion
2021-08-04
Completion
2021-08-04

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04468087 on ClinicalTrials.gov