Clinical trial: Combination Therapies to Reduce Carriage of SARS-Cov-2 and Improve Outcome of COVID-19 in Ivory Coast: a Phase Randomized IIb Trial (NCT04466241)

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).

          -  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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): The patient is a 38-year-old man with cough and body ache that started 3 days ago.  He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx.

Patient description (patient's own words): I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat.

Does the patient match the trial criteria? Entailment