COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04466241

Serge Eholié, M.D., Ph.D.

sergeholie@yahoo.fr

2020-07-10

Unknown

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: - patients over 18 years of age. - with sars-cov-2 infection confirmed by specific pcr. - with clinical manifestations of the infection, such as fever or cough, or otolaryngologic (orl) signs or respiratory difficulties, that started less than 7 days ago. - covid-19 specific treatment-naive. - women of childbearing age should accept the use of mechanical contraception during the study period. - informed consent signed by the patient.

- severe form of infection requiring oxygen therapy > 4l/min to achieve oxygen saturation > 94%. - patient whose weight is < 35kg. - pharmacological investigation contraindicating the introduction of a cyp450 inhibitor, in particular the cyp3a4 isoform. - known hypersensitivity to lopinavir, ritonavir, telmisartan, atorvastatin or their excipients. - renal impairment (egfr <30 ml/min, ckd-epi formulation). - known cirrhosis. - transaminases > 3n. - bilirubin > 2.6n. - electrocardiogram showing qtc> 500 ms. - hiv-infected patient without treatment or treated with protease inhibitors (lopinavir, darunavir, atazanavir). - ongoing exposure to statins. - contraindications to the use of statin: cpk > 5n, history of rhabdomyolysis or myopathies, increased risk when atorvastatin is administered with strong cyp3a4 inhibitors or transport proteins (cyclosporin, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole, letermovir, erythromycin, diltiazem, verapamil, fluconazole). - ongoing exposure to sartans. - contraindications to the use of telmisartan: patient on angiotensin-converting enzyme (ace) inhibitors, aliskiren or other angiotensin receptor blockers (arb). - curatorship or guardianship. - pregnancy or breastfeeding. - dementia or any other condition that prevents informed consent. - any reason that, at the discretion of the investigator, would compromise patient safety and cooperation in the trial.

3

ANRS, Emerging Infectious Diseases

18

100

Ivory Coast

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

294

Proportion of patients with undetectable nasopharyngeal swab SARS-CoV-2 PCR and C-reactive protein (CRP) < 27 mg/L at Day 11

None

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 1604, "treatment_name": "Lopinavir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1615, "treatment_name": "Lopinavir+ritonavir+telmisartan", "treatment_type": "Antivirals+cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1605, "treatment_name": "Atorvastatin+lopinavir+ritonavir", "treatment_type": "Metabolic agents+antivirals", "pharmacological_treatment": "Pharmacological treatment"}]