COVID-19
Conditions
Interventions
CVO plus
Placebo
Sponsors
PHARAMALAGASY
Eligibility
Sex/Gender
All
Inclusion 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
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 • History of allergic reactions to any investigational medical product ingredient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete clearance of viral load or significant progressive reduction of the viral load in OP swabs on days 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| time to improvement, duration of stay at hospital, development of adverse or severe adverse events, changes (if any) on heart, liver, kidney and lung functions and complete blood count. | — |
Countries
Madagascar
Contacts
Public ContactSedera Aurelien;Dominique MIORAMALALA;Razafimandimby
Data Manager CNARP;Clinician
Outcome results
None listed