| CTRI Number |
CTRI/2021/05/033867 [Registered on: 31/05/2021] Trial Registered Prospectively |
| Last Modified On: |
01/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Oral Doxycycline for COVID-19 patients |
|
Scientific Title of Study
|
A randomised controlled trial to assess the ability of doxycycline to reduce the need for ICU admission in patients with proven COVID-19 infection (DOXPREVENT.ICU)
|
| Trial Acronym |
DOXPREVENT.ICU |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raja Dhar |
| Designation |
Director and Head Pulmonologist |
| Affiliation |
YOU BREATHE WE CARE |
| Address |
Department of Pulmonology, Level 1 Speciality Clinics, Level-1,
CK Birla Hospitals
The Calcutta Medical Research Institute
7/2 Diamond Harbour Road,Kolkata
P-171/1 CIT Scheme, VII-M,
Kolkata-700054
Kolkata
WEST BENGAL
Kolkata-700027
India |
| Phone |
|
| Fax |
|
| Email |
pulmoresearch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raja Dhar |
| Designation |
Director and Head Pulmonologist |
| Affiliation |
YOU BREATHE WE CARE |
| Address |
Department of Pulmonology,
Level-1, Speciality clinics
C K Birla Hospitals
The Calcutta Medical Research Institute
7/2 Diamond Harbour Road,Kolkata
P-171/1 CIT Scheme VII-M
Kolkata-700054
Kolkata
WEST BENGAL
Kolkata-700027
India |
| Phone |
|
| Fax |
|
| Email |
pulmoresearch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raja Dhar |
| Designation |
Director and Head Pulmonologist |
| Affiliation |
YOU BREATHE WE CARE |
| Address |
Department of Pulmonology,
Level-1, Speciality clinics
CK Birla Hospitals
The Calcutta Medical Research Institute
7/2 Diamond Harbour Road,Kolkata
P-171/1 CIT Scheme VII-M
Kolkata-700054
Kolkata
WEST BENGAL
Kolkata-700027
India |
| Phone |
|
| Fax |
|
| Email |
pulmoresearch@gmail.com |
|
|
Source of Monetary or Material Support
|
| You Breathe We Care
P-171/1 CIT Scheme,VII-M,Kolkata-700054, West Bengal. |
|
|
Primary Sponsor
|
| Name |
You Breathe We Care |
| Address |
P-171/1 CIT Scheme VII-M,Kolkata-700054, West Bengal |
| Type of Sponsor |
Other [Non Profit research Trust] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Raja Dhar |
C.K.Birla Hospitals |
Department of pulmonology,1st level, Speciality clinic
The Calcutta Medical Research Institute
7/2 Diamond Harbour Road
Kolkata-700027
Kolkata
WEST BENGAL |
9831855512
pulmoresearch@gmail.com |
| Dr Rakesh Chawla |
Jaipur Golden Hospital |
Department of pulmonology
2, Naharpur Village Road,
Institutional Area, Sector 3, Rohini,Delhi
New Delhi
DELHI |
9810072860
rakeshchawla8888@gmail.com |
| Dr Sonia Dalal |
Sterling Hospital |
Department of Pulmonology,
Sterling Hospital
Race Course Road, Vadodara,Gujrat-390007
Vadodara
GUJARAT |
9898089310
drsoniadalal@hotmail.com |
| Dr Nagarjuna Maturu |
Yashoda hospital, Hyderabad |
Department of Pulmonology,Room No 217, 2nd Floor,A Block,RajBhavan Road, Somajiguda , Mathanagar, Hyderabad-5000082
Hyderabad
TELANGANA |
9100935638
arjunjipmer@yahoo.co.in |
| Dr Arjun Khanna |
Yashoda Superspeciality Hospital |
department of Pulmonology,
H-1 Ram Nagar,Kaushambi, Ghaziabad,UP 201012
Ghaziabad
UTTAR PRADESH |
8745008580
doc.khanna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , The Calcutta Medical Research Institute |
Approved |
| Institutional Ethics Committee, Jaipur Golden Hospital, Delhi |
Submittted/Under Review |
| Institutional Ethics Committee, Sterling hospital, Vadodara |
Submittted/Under Review |
| Institutional ethics Committee, Yashoda superspeciality Hospital, UP |
Submittted/Under Review |
| Institutional Ethics Committee,Yashoda Hospital,Hyderabad |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B338||Other specified viral diseases, (2) ICD-10 Condition: B342||Coronavirus infection, unspecified, (3) ICD-10 Condition: B342||Coronavirus infection, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Doxycycline |
Intention to treat with 200 mg oral doxycycline tablet qd for fourteen days on top of the standard of care (SOC). |
| Comparator Agent |
Usual care |
Standard care of COVID-19 as per local guidelines |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Able to give informed consent • Male or female, age 40to 90 years • Typical symptoms of COVUD-19 infection: new onset of or exacerbation of cough due to chronic respiratory illness, dyspnea, Increased body temperature (forehead T° >37.6°C; oral T°>38°C; axillary >37.5°C) • SARS-CoV-2 infection demonstrated by PCR • Admission to hospital within 10 days of onset of symptoms |
|
| ExclusionCriteria |
| Details |
Hypersensitivity to doxycycline; myasthenia gravis; pregnancy; hepatic failure (CHILD-Pugh score C); unable to give informed consent |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Admission to ICU |
Day zero to Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| death, mechanical ventilation, time to discharge, recovery from symptoms, resolution of fever, prolonged hospital stay (7days), supplemental oxygen required |
Day zero to day 14. |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/05/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is a randomized open label parallel group clinical trial. We propose a pragmatic clinical trial to test oral doxycycline as a therapy for newly hospitalized COVID-19 patients who are at high risk for progression to severe disease, with the main objective to reduce the burden of critical care (CC) services resulting from admission of severe patients in CC facilities. The choice of doxycycline is based on its broad antimicrobial efficacy, including antiviral properties; recent in silico analyses identifying it as a potential strong inhibitor of NSP5, a key pathogenic protein of SARS-CoV-2; its targeted anti-inflammatory properties and efficacy in human virus-induced hyperinflammation (in dengue fever); as well as its excellent safety profile, pharmacokinetic properties, low price, and its world-wide availability due to its status a one of the essential medicines defined by the WHO. Participants randomized to the interventional arm will take doxycycline 200 mg qd on top of the standard of care care whereas the standard care arm will not receive any doxycycline. Follow-up: patients discharged before the 14-day period of expected follow up will be contacted by telephone 2 days after discharge (to ensure they are well and convalescing well) and on day 14 (by telephone). |