Combination Therapies to Reduce Carriage of SARS-Cov-2 and Improve Outcome of COVID-19 in Ivory Coast: a Phase Randomized IIb Trial (INTENSE-COV)
- Conditions
- COVID-19
- Registration Number
- PACTR202007720062393
- Lead Sponsor
- Inserm ANRS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 294
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with undetectable nasopharyngeal swab SARS-CoV-2 PCR and C-reactive protein (CRP) < 27 mg/L at Day 11
- Secondary Outcome Measures
Name Time Method Proportion of patients with clinical improvement on the 7-point ordinal scale at Day 11;Kinetics of SARS-CoV-2 viral load ;Death rate at Day 11 and Day 28 ;All causes of death and Acute respiratory distress syndrome (ARDS) at Day 28 ;Time to hospital discharge ;Duration of oxygen supplementation ;Prevalence of grade III or IV adverse events;Residual concentration of lopinavir, telmisartan and atorvastatin ;Evolution of inflammatory and immunological markers ;Evolution of endothelial activation markers ;Absence of symptoms at Day 28 ;Proportion of patients with good results according to HIV status ;Number of contact cases infected by COVID-19 at Day 28