Safety and efficacy of antiviral combination therapy in symptomatic patients of Covid-19 infection - a randomised control trial

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2020/06/025575
• Date of registration: 03-06-2020
• Prospective Registration: Yes
• Primary sponsor: AIIMS Rishikesh
• Public title: Safety and efficacy of antiviral combination therapy in symptomatic patients of Covid-19 infection - a randomised control trial
• Scientific title: Safety and efficacy of antiviral combination therapy in symptomatic patients of Covid-19 infection - a randomised control trial - SEV-Covid Trial
• Date of first enrolment: 15-06-2020
• Target sample size: 175
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43076
• Study type: Interventional
• Study design: Randomized, Parallel Group, Multiple Arm Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Alternation Blinding and masking:Open Label
• Phase: Phase 3/ Phase 4

Countries of recruitment

India

Contacts

• Name: Prasan Kumar Panda
• Affiliation: AIIMS Rishikesh

• Name: Prasan Kumar Panda
• Affiliation: AIIMS Rishikesh

Key inclusion & exclusion 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: 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



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Intervention(s)

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 (Antipyretic, Antiallergic, Cough Suppressant)
6. Treatment of Comorbid Diseases
7. Oseltamivir (75 mg BD) for patient who are tested positive for H1N1
If the patient improves clinically the same treatment will be continued. If the patient do-not improve or shows sign of severity (mentioned above) the patient will be shifted to the severity arm (S-group) of the clinical trial with randomization again.
Intervention2: Standard Treatment for severe patients: (STs): 1. Strict Isolation
2. Standard Precautions (Hand hygiene, Cough Etiquette, Wear surgical mask)
3. Fluid Therapy
4. Supportive Pharmacotherapy (Antipyretic, Antiallergic, Cough Suppressant)
5. Oxygen supplementation (As required)
6. Invasive ventilation (As required)
7. Antibiotic agents for other associated infections (according to 2019 ATS/IDSA guidelines for non-ICU and ICU patients)
8. Vasopressor support
9. Renal-replacement therapy
10. Treatment of Comorbid Diseases
11. Oseltamivir (75 mg BD) for patient who are tested positive for H1N1
Patients will be assessed for clinical improvement in every 48-72 hours of treatment. In case the patient do not respond to the current treatment regimen the patient will be shifted to alternative regimen in the same treatment group. If the patient progress in the same group then patient will be shifted to biologics (Tocilizumab). In case the patient do not respond in the next 48-72 hours and continue to deteriorate on the current treatment then the all experimental treatment will be stopped and Standard Treatment (STs) will be continued.

Intervention3: Standard Treatment (

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

NIL

Source(s) of Monetary Support

AIIMS, Rishikesh, Uttarakhand, 249203

Ethics review

Status: Approved
Approval date: 30/05/2020
Contact:

IEC, AIIMS Rishikesh