Status:
COMPLETED
Antiviral Agents Against COVID-19 Infection
Lead Sponsor:
Hospital do Coracao
Conditions:
COVID-19
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
PHASE3
Brief 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 ...
Detailed Description
We have planned an randomized, adaptive, placebo-controlled, double-blind study to be carried out in 3 seamless stages. The first two stages are phase 2 studies with a third stage phase 3 to be conduc...
Eligibility Criteria
Inclusion
- 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
- Symptom duration \<= 9 days
- SpO2 \<= 94% in room air or need for supplemental oxygen to maintain SpO2\> 94%
- The patient consents to participate in the study and is willing to comply with all study procedures, including the collection of virology samples
Exclusion
- Patients in need of respiratory support with invasive mechanical ventilation;
- Alanine Transaminase (ALT) or Aspartate Transaminase (AST) \> 5 times the upper limit of normal;
- Total bilirubin \> 2 mg/dL;
- Platelets \<50,000 cel/L;
- Total neutrophil count \<750 cell/L;
- 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;
- 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;
- 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;
- Pregnant or breast feeding patients;
- Known allergy or hypersensitivity to any study drug;
- 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;
- Patients currently using nucleoside or nucleotide analog drugs for any indication;
- Corrected Q interval T\> 480 on the electrocardiogram;
- Heart rate \<55 bpm;
- Patients in use or who recently used (\<90 days) amiodarone;
- 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.
Key Trial Info
Start Date :
February 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 4 2021
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT04468087
Start Date
February 15 2021
End Date
August 4 2021
Last Update
March 22 2024
Active Locations (1)
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1
Hospital do Coracao
São Paulo, São Paulo, Brazil, 04005-000