COVID-19 trials registries data warehouse

https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=15764

Sedera Aurelien;Dominique MIORAMALALA;Razafimandimby

sedera.mioramalala@gmail.com; domrazafimandimby9@gmail.com

2021-03-19

Not recruiting

RCT

Randomized

Factorial

Blind label

single-center

Treatment

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.

• 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

2

PHARAMALAGASY

18

85

Madagascar

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

338

complete clearance of viral load or significant progressive reduction of the viral load in OP swabs on days 28

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 3

[{"arm_notes": "", "treatment_id": 2307, "treatment_name": "Artemisinin+cineol", "treatment_type": "Antimalarials+others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]