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CTRI Number  CTRI/2020/06/025575 [Registered on: 03/06/2020] Trial Registered Prospectively
Last Modified On: 12/08/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Safety and efficacy of antiviral combination therapy in symptomatic patients of Covid-19 infection - a randomised control trial  
Scientific Title of Study   Safety and efficacy of antiviral combination therapy in symptomatic patients of Covid-19 infection - a randomised control trial 
Trial Acronym  SEV-Covid Trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prasan Kumar Panda 
Designation  Assistant Professor  
Affiliation  AIIMS Rishikesh  
Address  Department of General Medicine, Sixth Floor, College Block , AIIMS Rishikesh Dehradun UTTARAKHAND 249203 India

Dehradun
UTTARANCHAL
249203
India 
Phone  9868999488  
Fax    
Email  prasan.med@aiimsrishikesh.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Prasan Kumar Panda 
Designation  Assistant Professor  
Affiliation  AIIMS Rishikesh  
Address  Department of General Medicine, Sixth Floor, College Block , AIIMS Rishikesh Dehradun UTTARAKHAND 249203 India


UTTARANCHAL
249203
India 
Phone  9868999488  
Fax    
Email  prasan.med@aiimsrishikesh.edu.in  
 
Details of Contact Person
Public Query
 
Name  Prasan Kumar Panda 
Designation  Assistant Professor  
Affiliation  AIIMS Rishikesh  
Address  Department of General Medicine, Sixth Floor, College Block , AIIMS Rishikesh Dehradun UTTARAKHAND 249203 India


UTTARANCHAL
249203
India 
Phone  9868999488  
Fax    
Email  prasan.med@aiimsrishikesh.edu.in  
 
Source of Monetary or Material Support  
AIIMS, Rishikesh, Uttarakhand, 249203  
 
Primary Sponsor  
Name  AIIMS Rishikesh  
Address  Research cell, AIIMS, Rishikesh, Uttarakhand, 249203  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prasan Kumar Panda  AIIMS  Department of General Medicine, Sixth Floor, College Block, Rishikesh Dehradun UTTARAKHAND
Dehradun
UTTARANCHAL 
9868999488

prasan.med@aiimsrishikesh.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, AIIMS Rishikesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Hydroxychloroquine, Ribavirin, ST-NS  Hydroxychloroquine 400 mg twice on first day followed by 400 mg per oral daily for 10 days + Ribavirin (2.4 g orally as a loading dose followed by 1.2 g orally every 12 hours) for 10 days + Standard Treatment (STNS)6 
Comparator Agent  Hydroxychloroquine, Ribavirin, ST-S  Hydroxychloroquine 400mg BD on day1 followed by 400 mg once daily + Ribavirin (2.4 g orally as a loading dose followed by 1.2 g orally every 12 hours) for 10 days + Standard Treatment (STs)  
Comparator Agent  Lopinavir, Ritonavir, Ribavirin, ST-S  Lopinavir(400mg) + Ritonavir (100mg) two tablets twice daily+ Ribavirin (2.4 g orally as a loading dose followed by 1.2 g orally every 12 hours) for 10 days + Standard Treatment (STs)6 
Intervention  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 and randomization again 
Intervention  Standard Treatment(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 and laboratory improvements in 72 hours of treatment. In case the patient does not respond to the current treatment regimen the patient will be shifted to institute protocol for current practice of treatment.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  1. Use of medications that are contraindicated with lopinavir/ritonavir, Hydroxychloroquine/ Chloroquine and that cannot be replaced or stopped
4. Physician’s decision that participation in the trial is not in patients’ 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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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 specimen  
72hrly 
 
Secondary Outcome  
Outcome  TimePoints 
1. All causes mortality
2. Frequency of respiratory progression
Defined as SPO2≤ 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
 
Upto 28days 
 
Target Sample Size   Total Sample Size="175"
Sample Size from India="175" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   15/06/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Aim: To assess the safety and efficacy of Antiviral Combination Therapy In Symptomatic Patients of COVID-19 Infection

Objectives:

1.    To compare the safety and efficacy of Hydroxychloroquine and standard treatment in patients of non-severe COVID-19 infection

2.    To compare the safety and efficacy of Lopinavir-ritonavir combination and Hydroxychloroquine with Ribavirin in patients of severe COVID-19 infection

Justification for study:  COVID 19 infection had become a pandemic. The presentation of the disease is highly variable. The treatment options for the disease are limited at present. For non-severe patient’s supportive treatment forms the mainstay of management. Various regimens have been tried in critically ill patients. Hydroxychloroquine, Lopinavir-ritonavir combination have been tried in clinical trials with limited success. The present study is planned to explore the combination of the above drugs with Ribavirin in severe cases of COVID-19 infection.
 
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