Status:
COMPLETED
Combination Therapies to Reduce Carriage of SARS-Cov-2 and Improve Outcome of COVID-19 in Ivory Coast: a Phase Randomized IIb Trial
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
University of Bordeaux
PACCI Program
Conditions:
COVID-19
COVID-19 Drug Treatment
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
In January 2020, the new SARS-CoV-2 coronavirus was identified in China. The disease caused by this coronavirus was named COVID-19 by the World Health Organization (WHO). Since March 11, 2020, the WHO...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2021
Estimated Enrollment :
294 Patients enrolled
Trial Details
Trial ID
NCT04466241
Start Date
November 27 2020
End Date
November 1 2021
Last Update
December 27 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Service des Maladies Infectieuses et Tropicales, Centre Hospitalier et Universitaire (CHU) Treichville
Abidjan, Côte d’Ivoire, 01 BP V3
2
Centre de Traitement des Maladies Infectieuses (CTMI), CHU de Yopougon
Abidjan, Côte d’Ivoire, 21 BP 632