Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Standard Treatment (STns): 1. Strict Isolation
2. Standard Precautions (Hand hygiene, Cough Etiquette, Wear surgical mask)
3. Hydration
4. Proper Nutrition
5. Supportive Pharmacotherapy
Sponsors
AIIMS Rishikesh
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. All causes mortality 2. Frequency of respiratory progression Defined as SPO2â?¤ 94% on room air or PaO2/FiO2 300mmHg and requirement for supplemental oxygen or more advanced ventilator support. 3. Time to defervescence (in those with fever at enrolment) 4. Frequency of requirement for supplemental oxygen or non-invasive ventilation 5. Frequency of requirement for mechanical ventilation 6. Frequency of serious adverse events Timepoint: Upto 28days | — |
Primary
| Measure | Time frame |
|---|---|
| 1. Time to Clinical recovery (TTCR) 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. 2. Time to 2019-nCoV RT-PCR negative in upper respiratory tract specimenTimepoint: 72hrly | — |
Countries
India
Contacts
Public ContactPrasan Kumar Panda
AIIMS Rishikesh
Outcome results
None listed