Antiviral Agents Against COVID-19 Infection

• Status: Recruiting
• Trial end date: 2022-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital do Coracao
• Treatments: Atazanavir Sulfate

Criteria

Inclusion Criteria:

1. Adults (≥ 18 years) hospitalized with COVID-19:

• SARS-CoV-2 positive RT-PCR or Antigen test

• Typical clinical history and chest CT with typical findings, pending RT-PCR for SARS-CoV-2

2. Symptom duration <= 9 days

3. SpO2 <= 94% in room air or need for supplemental oxygen to maintain SpO2> 94%

4. The patient consents to participate in the study and is willing to comply with all study procedures, including the collection of virology samples

Exclusion Criteria:

1. Patients in need of respiratory support with invasive mechanical ventilation;

2. Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 5 times the upper limit of normal;

3. Total bilirubin > 2 mg/dL;

4. Platelets <50,000 cel/L;

5. Total neutrophil count <750 cell/L;

6. Renal dysfunction (estimated glomerular filtration rate [eGFR] <30 mL / min / 1.73 m2, using the MDRD or CKD-EPI method); and pre-defined renal failure stage 3 according to AKINx classification with serum creatinine> 4 mg / dl or patient already on renal replacement therapy;

7. Previously known liver disease (liver cirrhosis), defined as a report by the participant or written in the respective cirrhosis chart, esophageal varices, or the presence of clinical ascites on examination;

8. Decompensated congestive heart failure defined as the presence of dyspnea, edema of the lower limbs or rales on pulmonary auscultation, jugular turgency or chest X-ray with signs of pulmonary congestion;

9. Pregnant or breast feeding patients;

10. Known allergy or hypersensitivity to any study drug;

11. Hepatitis C carrier (HCV RNA positive), active Hepatitis B (positive surface antigen in the past), or HIV (ELISA and confirmatory Western Blot in the past). New screening tests are NOT required;

12. Patients currently using nucleoside or nucleotide analog drugs for any indication;

13. Corrected Q interval T> 480 on the electrocardiogram;

14. Heart rate <55 bpm;

15. Patients in use or who recently used (<90 days) amiodarone;

16. Women of childbearing potential and men with a partner of childbearing potential who do NOT agree to use two contraceptive methods (including barrier method) for 100 days.