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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  
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 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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  B972||Coronavirus as the cause of diseases classified elsewhere, 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 
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.

 
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