PACTR202007720062393
Not yet recruiting
Phase 2
Combination Therapies to Reduce the Nasopharyngeal Carriage of SARS-CoV-2 and Improve the Outcome of COVID-19 Infection in Ivory Coast (INTENSE-COV): a Phase IIb Randomized Clinical Trial
Inserm ANRS0 sites294 target enrollmentJuly 2, 2020
ConditionsCOVID-19
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Inserm ANRS
- Enrollment
- 294
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Exclusion Criteria
- •\- 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).
Outcomes
Primary Outcomes
Not specified
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