Status:
TERMINATED
Safety and Efficacy of Maraviroc and/or Favipiravir With Standard Therapy in Severe COVID-19 Adults
Lead Sponsor:
Hospital General de México Dr. Eduardo Liceaga
Collaborating Sponsors:
CCINSHAE. Secretaría de Salud. México
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Conditions:
COVID-19
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Phase 2, randomized, open-label study to evaluate the safety and efficacy of maraviroc, favipiravir, and both drugs administered along with currently used therapy in hospitalized patients with pulmona...
Detailed Description
The COVID-19 pandemic (Coronavirus Disease-19) caused by SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) has caused more that 10 million infections worldwide, with a general mortality of ...
Eligibility Criteria
Inclusion
- With severe non-critical stage of COVID at the time of admission.
- Patients tested positive for SARS-CoV-2 confirmed by PCR (Polymerase Chain Reaction) or quick antigen test
- Within the first 12 days post appearance of symptoms
- With at least one of the following risk factors: Diabetes mellitus (DM), obesity (BMI\>30, hypertension, age \> 65 years.
- Respiratory rate 25-34/min and no signs of respiratory distress.
- With at least two of the following indicators of severity: SpO2 81-90%, PaFi 150-300 mmHg, FiO2\>60% , lung damage in thorax radiographic image =\> 25% as determined by RALE score (an equivalent to 2-4).
- Normal liver function (Considered up to a fivefold increase above the normal limits of hepatic transaminases)
- Signed informed consent
Exclusion
- Pregnant or lactating women
- Patients already participating in another clinical study
- Oxygen saturation \< 70% (ambient)
- Clinical evidence of an infectious disease different from COVID at the time of admission
- Chronic kidney failure
- Coronary disease
- Glomerular filtration rate \< 30ml/min/1.73 m2 and known history of preexisting chronic renal failure (Chronic kidney disease stages 4-5)
- Known history of HCV, HBV and/or clinical signs of hepatic liver failure.
- Any type of cancer
- HIV and/or any anti retroviral treatment
- Inability to freely decide to participate
- Psychotropics treatment
- Erythromycin treatment
- Polydrug use (Defined as more than two addictions combined)
- With transplant background
- With any autoimmune disorder
- With known hypersensibility to maraviroc and/or favipiravir
- On invasive mechanical ventilation at the time of randomization
Key Trial Info
Start Date :
July 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2022
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04475991
Start Date
July 13 2021
End Date
March 25 2022
Last Update
June 3 2022
Active Locations (1)
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1
Hospital General de México "Dr. Eduardo Liceaga"
Mexico City, Mexico City, Mexico, 06720