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CTRI Number  CTRI/2022/07/043679 [Registered on: 04/07/2022] Trial Registered Prospectively
Last Modified On: 09/12/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Antihistamines for treatment of Long COVID 
Scientific Title of Study   Antihistamines for treatment of Long COVID – A placebo controlled double blinded Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arjun M C 
Designation  Research Fellow  
Affiliation  St. Johns Research Institute 
Address  Department of Biostatistics St Johns Research Institute St. Johns Medical College 100 Feet Rd, John Nagar, Koramangala, Bengaluru, Karnataka, India
St. Johns Medical College 100 Feet Rd, John Nagar, Koramangala, Bengaluru, Karnataka, India
Bangalore
KARNATAKA
560034
India 
Phone    
Fax    
Email  dr.arjun.aiims@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arjun M C 
Designation  Research Fellow 
Affiliation  St. Johns Research Institute 
Address  Department of Biostatistics St. Johns Research Institute St. Johns Medical College 100 Feet Rd, John Nagar, Koramangala, Bengaluru, Karnataka, India
St. Johns Medical College 100 Feet Rd, John Nagar, Koramangala, Bengaluru, Karnataka, India
Bangalore
KARNATAKA
560034
India 
Phone    
Fax    
Email  dr.arjun.aiims@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Arjun M C 
Designation  Research Fellow 
Affiliation  St. Johns Research Institute 
Address  Department of Biostatistics St. Johns Research Institute St. Johns Medical College 100 Feet Rd, John Nagar, Koramangala, Bengaluru, Karnataka, India
St. Johns Medical College 100 Feet Rd, John Nagar, Koramangala, Bengaluru, Karnataka, India
Bangalore
KARNATAKA
560034
India 
Phone    
Fax    
Email  dr.arjun.aiims@gmail.com  
 
Source of Monetary or Material Support  
Clinical Research Centre Dept of Physiology St. John’s National Academy of Health Sciences, Sarjapur Road, Bangalore Karnataka, India 560034 
 
Primary Sponsor  
Name  Dr Arjun M C 
Address  Department of Biostatistics, St. Johns Research Institute: SJRI, 100 Feet Rd, John Nagar, Koramangala, Bengaluru, Karnataka 560034 
Type of Sponsor  Other [Self] 
 
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 Arjun M C  St. John’s Medical College  Department of Biostatistics Marathahalli - Sarjapur Rd, beside Bank Of Baroda, John Nagar, Koramangala, Bengaluru, Karnataka 560034
Bangalore
KARNATAKA 		 7560921542

dr.arjun.aiims@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee St. John’s Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B338||Other specified viral diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Loratadine 10 mg   Loratadine 10 mg once a day for 14 days 
Comparator Agent  Placebo  Placebo tablets once a day for 14 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Adults diagnosed with COVID-19 and presenting with Long COVID symptoms after 3 months of COVID-19 diagnosis (Diagnosed with RTPCR or RAT only) 
 
ExclusionCriteria 
Details  Pregnant and lactating women
Patients who are severely ill, bedridden or cannot follow up in hospital
Patients having Diagnosed Liver or kidney diseases
Those who do not consent
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in the intensity of symptoms after intervention. At baseline the symptoms will be recorded using a Binary (Yes/No) symptoms grid and at follow-up the same symptoms reassessed for change (Identical, worse, better, absent). Outcome will be reported as proportion of people who experienced change in symptoms.
 		 All participants will be followed up for a period of 14 days from the date of enrolment. Follow-up will be done telephonically. 
 
Secondary Outcome  
Outcome  TimePoints 
Decrease in Chalder Fatigue scale score from baseline to follow-up
 		 All participants will be followed up for a period of 14 days from the date of enrolment. Follow-up will be done telephonically. 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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 4 
Date of First Enrollment (India)   15/07/2022 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details   The findings will be published in a peer-reviewed journal, after completion of study. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Long COVID, or Post-acute Sequelae of SARS-CoV-2 Infection, is a debilitating condition with no specific treatment protocol. There are case reports and an observational study which shows that the Over the counter (OTC) Antihistamines maybe helpful in the treatment of Long COVID, probably by the drugs effect on stabilising mast cells. The lack of evidence and recommendation from the previous study point towards the need for a randomized control trial which can generate quality evidence for the use of antihistamine in treatment of Long COVID.

We plan to carry out a double blinded randomised placebo-controlled trial to determine the efficacy of antihistamine (Loratadine 10mg) in the treatment of Long COVID symptoms. We will recruit 64 participants (32 each in intervention and placebo) who are suffering from Long COVID symptoms. The patients will be recruited after screening of COVID-19 patients who were diagnosed at least 3 months before the date of screening. The participants should be aged 18 years and above, and must not be pregnant, lactating, severely ill and bedridden, or have any liver and kidney diseases.

The primary objective is to determine the efficacy of Antihistamines in improving the symptoms of Long COVID patients measured by the change in intensity of symptoms recorded in a binary (Present/Absent) symptoms grid, compared to placebo, when given over a period of 14 days. The secondary objective is to assess fatigue using Chalder Fatigue scale and quantify the improvement in fatigue after giving Antihistamine for 14 days, compared to placebo.

The recruitment and conduct of trial will take place at St. John’s Hospital, St. Johns Academy of Health Sciences, Bangalore after obtaining Ethics approval from institute ethics committee. Written informed consent will be taken before recruitment of patients and Data Monitoring and Safety Committee (DMSC) will monitor the conduct of the trial.

If the results of this trial shows that antihistamines are effective in management of Long COVID symptoms, it will be a breakthrough and relief to millions of patients suffering from Long COVID.

 
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