Safety and efficacy of antiviral combination therapy in symptomatic patients of Covid-19 infection - a randomised control trial
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/06/025575
- Lead Sponsor
- AIIMS Rishikesh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Age >=18 years at time of participation in the study
2.Laboratory (RT-PCR) confirmed infection with 2019-nCoV
3.Willingness of study participant to accept randomization to any assigned treatment arm
4.Must agree not to enrol in another study of an investigational agent prior to completion of the present study
1.Use of medications that are contraindicated with lopinavir/ritonavir, Hydroxychloroquine/ Chloroquine and that cannot be replaced or stopped
4.Physicianâ??s decision that participation in the trial is not in patientsâ?? best interest, or any condition that does not allow the protocol to be followed safely
5.Patient already on antiretroviral therapy with Lopinavir-Ritonavir based regimen or on Hydroxychloroquine/Chloroquine
6.Any known contraindication to test drugs such as retinopathy and QT prolongation
7.Known allergic reaction to Lopinavir-ritonavir, Hydroxychloroquine/ Chloroquine
8.Pregnant or breastfeeding females
9.Receipt of any experimental treatment for 2019-nCoV (off-label, compassionate use, or trial related) within 30 days prior to participation in the present study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Time to Clinical recovery (TTCR) <br/ ><br>TTCR is defined as the time (in hours) from initiation of study treatment (active or placebo) until normalisation of fever, respiratory rate, and oxygen saturation, and alleviation of cough, sustained for at least 72 hours. <br/ ><br> <br/ ><br>2.Time to 2019-nCoV RT-PCR negative in upper respiratory tract specimenTimepoint: 72hrly
- Secondary Outcome Measures
Name Time Method 1.All causes mortality <br/ ><br>2.Frequency of respiratory progression <br/ ><br>Defined as SPO2â?¤ 94% on room air or PaO2/FiO2 300mmHg and requirement for supplemental oxygen or more advanced ventilator support. <br/ ><br>3.Time to defervescence (in those with fever at enrolment) <br/ ><br>4.Frequency of requirement for supplemental oxygen or non-invasive ventilation <br/ ><br>5.Frequency of requirement for mechanical ventilation <br/ ><br>6.Frequency of serious adverse events <br/ ><br>Timepoint: Upto 28days