CTRI Number |
CTRI/2020/06/026193 [Registered on: 28/06/2020] Trial Registered Prospectively |
Last Modified On: |
28/06/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
A study of drug Lithium on patients of Covid 19 disease |
Scientific Title of Study
|
A randomized control study to evaluate the therapeutic effects of Lithium in Covid-19 patients |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Sumit Sural |
Designation |
Director Professor |
Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
Address |
Dept of Orthopedics
Lok Nayak Hospital
Delhi
Central DELHI 110002 India |
Phone |
9968604323 |
Fax |
|
Email |
sumitsural@hotmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Sumit Sural |
Designation |
Director Professor |
Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
Address |
Dept of Orthopedics
Lok Nayak Hospital
Delhi
Central DELHI 110002 India |
Phone |
9968604323 |
Fax |
|
Email |
sumitsural@hotmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Sumit Sural |
Designation |
Director Professor |
Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
Address |
Dept of Orthopedics
Lok Nayak Hospital
Delhi
Central DELHI 110002 India |
Phone |
9968604323 |
Fax |
|
Email |
sumitsural@hotmail.com |
|
Source of Monetary or Material Support
|
Maulana Azad medical college and associated Lok nayak
Hospital
Bahadur shah zafar marg
Delhi 110002 |
|
Primary Sponsor
|
Name |
Maulana azad medical college |
Address |
Maulana azad medical college
Bahadur shah zafar marg
delhi |
Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Sumit Sural |
Lok Nayak Hospital |
All Inpatients in Medicine, Surgery, ICU, Pediatrics,Orthopedic wards admitted at Lok Nayak Hospital.
Bahadur shah zafar marg
Delhi 110002 Central DELHI |
9999614742
sumitsural@hotmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
maulana azad medical college and associated hospitals |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, (2) ICD-10 Condition: B342||Coronavirus infection, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Group L |
Tablet Lithium carbonate 600mg twice daily as add on therapy with Tablet Hydyoxychloroquine 400mg once daily with or without Azithromycin 500mg once daily for 5 days |
Comparator Agent |
Standard care of therapy(Group s) |
Tablet Hydroxychloroquine 400mg once daily with or without Tablet Azithromycin 500mg OD for 5 and placebo for 5 Days |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
1.Age between 18 and 70yrs
2.Positive Covid test report as per reverse transcriptase polymerase chain reaction (RT PCR) of oronasopharyngeal swabs.
3.Respiratory rate more than 30 per minute.
4.SpO2 93% or less.
|
|
ExclusionCriteria |
Details |
1.Known case of hypothyroidism
2.Renal insufficiency; Serum creatinine levels more than 1.3 mg/dl
3.Cardiac arrhythmia and cardiac disease
4.Patients on NSAID
5.Known history of QTc prolongation on ECG
6.Contraindication or allergy to hydroxychloroquine
7.Retinal eye disease
8.Pregnancy/breastfeeding |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Mortality |
At week 3 |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. Time taken for conversion to Covid negative status
2.Morbidity
3. Adverse events
iii.Adverse drug monitoring |
1.From day of report of first sample i.e.day 0, day 3, day 6
2.During stay in hospital i.e. day 3, day 6
3. During stay in hospital, day 3,day 6, day 10 |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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
|
N/A |
Date of First Enrollment (India)
|
30/07/2020 |
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)
|
Not Applicable |
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)?
|
Brief Summary
|
COVID -19 pandemic has affected the world cutting across geographical, cultural or religious boundaries. With more than 4.5 million COVID positives and three hundred thousand deaths, it has emerged as most dangerous threat and tragedy to human race. Since till date no effective treatment is available, need is to look for drugs with potential in reducing viral replication. Lithium carbonated which is being prescibed for Bipolar disorder have shown potential in many invitro studies to inhibit other avian corona virus growth in cell culture.It directly impedes viral replication in animal and in vitro studies. This was first discovered in the 1980’s with the herpes family of viruses. Lithium treated and prevented labile herpes, whether taken orally or as a topical ointment. Since then, lithium has demonstrated antiviral activity against over a dozen viruses, both DNA and RNA types. Studies have shown that porcine epidemic diarrhoea virus (PEDV), a member of the Coronaviridae family, requires the P13K/Akt/GSK-3a/b pathway, which can be targeted at GSK-3b by lithium. We will be enrolling 100 patients of Covid 19 who are severely symptomatic, divide them in 2 groups, one group will received standard care of therapy i.e. hydroxycloroquine, azithromycin or both and other group will receive Lithium carbonate at dose of 600mg twice daily with standard care of therapy for 6 days. |