PACTR202103601407640
Completed
Phase 3
Randomized clinical trial, phase 3, to evaluate the efficacy of CVO + versus placebo for the treatment of COVID-19.
PHARAMALAGASY0 sites338 target enrollmentMarch 19, 2021
ConditionsCOVID-19
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- PHARAMALAGASY
- Enrollment
- 338
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Study participant (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
- •Understands and agrees to comply with planned study procedures.
- •Agrees to the collection of OP swabs and venous blood per protocol.
- •Male or non\-pregnant female adult \=18 years of age at time of enrolment.
- •Laboratory\-confirmed SARS\-CoV\-2 infection as determined by PCR nasopharyngeal swab.
- •Illness of any duration, and at least one of the follow ing:
- •Clinical assessment (evidence of rales/crackles on exam) or
- •Requiring mechanical ventilation and/or supplemental oxygen.
- •Creatinine \= 110 umol/L, creatinine clearance rate (EGFR) \= 60 ml / min / 1\.73m2, AST and ALT \= 5 × ULN, TBIL \= 2 × ULN;
- •A Normal ECG Baseline result, which is maintained throughout the study.
Exclusion Criteria
- •ALT/AST \> 5 times the upper limit of normal.
- •Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR \< 30\)
- •Pregnancy or breast feeding.
- •Anticipated transfer to another hospital w hich is not a study site w ithin 72 hours.
- •Allergy to any study medication
- •Shortness of breath in resting position
- •Known prolonged QT syndrome
- •Use of concomitant medications that prolong the QT/QTc interval
- •Participant with other viral pneumonia
- •Participants with allergies to artemisinin containing products
Outcomes
Primary Outcomes
Not specified
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