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CTRI Number  CTRI/2021/05/033836 [Registered on: 27/05/2021] Trial Registered Prospectively
Last Modified On: 20/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Safety and Efficacy of ATR-002 for Hospitalized Patients with COVID-19 
Scientific Title of Study   RESPIRE - A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Clinical Trial to Evaluate the Safety and Efficacy of ATR-002 in Adult Hospitalized Patients with COVID-19 
Trial Acronym  ATR-002-202 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
2020-004206-59  EudraCT 
ATR-002-202 version 3.2 IND dated 07 May 2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sabah Siddiqui 
Designation  Principal Investigator 
Affiliation  All India Institute of Medical Sciences Raipur 
Address  Department of General Medicine, D-Block, All India Institute of Medical Sciences Raipur
Gate No 1 Great Eastern Rd opposite Gurudwara AIIMS Campus Tatibandh Raipur Chhattisgarh
Raipur
CHHATTISGARH
492099
India 
Phone  8518881911  
Fax    
Email  dr.sabah@aiimsraipur.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepa Arora 
Designation  Director-Clinexel Life Sciences Private Limited 
Affiliation  Clinexel Life Sciences Private Limited 
Address  Unit 206 The Corporate Park Sector-18 Vashi
Navi Mumbai
Thane
MAHARASHTRA
400703
India 
Phone  9820648395  
Fax    
Email  deepaarora@clinexel.com  
 
Details of Contact Person
Public Query  
Name  Dr Deepa Arora 
Designation  Director-Clinexel Life Sciences Private Limited 
Affiliation  Clinexel Life Sciences Private Limited 
Address  Unit 206 The Corporate Park Sector-18 Vashi
Navi Mumbai
Thane
MAHARASHTRA
400703
India 
Phone  9820648395  
Fax    
Email  deepaarora@clinexel.com  
 
Source of Monetary or Material Support  
Atriva Therapeutics GmbH Eisenbahnstr. 1 72072 Tuebingen Germany 
 
Primary Sponsor  
Name  Atriva Therapeutics GmbH  
Address  Atriva Therapeutics GmbH Eisenbahnstr. 1 72072 Tuebingen Germany 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Germany
India
Netherlands
South Africa
Spain  
Sites of Study
Modification(s)  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prabhat Ranjan sinha  Aakash Healthcare Pvt ltd  Aakash Healthcare superspeciality Hospital, Plot Road no 201, Dwarka Sector 3, New Delhi 110075
North West
DELHI 		 01143388736
01143388888
drprabhat.ranjan@aakashhealthcare.com 
Dr Sabah Siddiqui  AIIMS Raipur  Department of General Medicine, D-Block, Gate No, 1, Great Eastern Rd, opposite Gurudwara, AIIMS Campus, Tatibandh, Raipur, Chhattisgarh 492099
Raipur
CHHATTISGARH 		 8518881911

dr.sabah@aiimsraipur.edu.in 
Dr Mohammad Shameem  Jawaharlal Nehru Medical College AMU  Department of Tuberculosis and respiratory diseases, Professor Interventional Pulmonology Jawaharlal Nehru Medical College AMU Aligarh Uttar Pradesh 202001 India
Aligarh
UTTAR PRADESH 		 9412731835

mshameem@myamu.ac.in 
Dr Ajay Bharat Jhaveri  Kasturba Hospital for Infectious Diseases   Sane Guruji Marg, Arya Nagar, chinchpokli, Mumbai, Maharashtra 400034
Mumbai
MAHARASHTRA 		 9867433330

drajayjhaveri@gmail.com 
Dr Anand Nikalje  Mahatma Gandhi Missions Medical College and Hospital  Building B Clinical Research Unit 3rd Floor Building A N6 CIDCO Aurangabad
Aurangabad
MAHARASHTRA 		 02406601100

anandnikalje@rediffmail.com 
Dr Mahavir Modi  Ruby Hall Clinic  Department of Pulmonary Medicine, Ruby Hall clinic, 40 Sassoon road sangamwadi, Pune Maharashtra 411001
Pune
MAHARASHTRA 		 02066455495
02066455628
drm_modi@yahoo.co.in 
Dr Ganesh Manudhane  Seven Hills Hospital  Department of Cardiology Marol Maroshi Rd Mahavir Nagar Pandit Dindayala Upadhaya Nagar Andheri East Mumbai 400059
Mumbai (Suburban)
MAHARASHTRA 		 7276705766

drganeshmanudhane1098@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Bhatia Hospital, Medical Research Society Ethics Committee  Approved 
Institutional Ethics Committee AIIMS Raipur  Approved 
Institutional Ethics Committee AMU Aligarh  Approved 
Institutional Ethics Committee, Aakash Healthcare Superspeciality hospital, New Delhi   Approved 
Jaslok Hospital Institutional Ethics Committee, Kasturba Hospital,Mumbai  Approved 
MGM Ethics Committee for Research On Human Subject  Approved 
Poona Medical Research Foundation, Ruby Hall Clinic, Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
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 
Intervention  ATR-002  900 mg (6 tablets) once daily on Day 1 600 mg (4 tablets) once daily on Days 2 to 6 
Comparator Agent  Matching Placebo  6 tablets once daily on Day 1 and 4 tablets once daily on Days 2 to 6 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Informed Consent
1. Capable of giving signed informed consent as described in Section 10.1.3, which includes
compliance with the requirements and restrictions listed in the informed consent form (ICF)
and in this protocol.
Age
2. Study participant must be at least 18 years of age at the time of signing the ICF.
Type of Participant and Disease Characteristics
3.1 Study participants in India with a laboratory confirmed diagnosis of SARS-CoV-2 infection
presenting as moderate COVID-19 requiring hospitalization for COVID-19 and for medical
reasons (see Section 8 and CLINICAL MANAGEMENT PROTOCOL: COVID-19,
Government of India, Version 5, 03.07.20).
3.2 At least one of the following clinical features need to be present:
Dyspnea
Hypoxia
Fever
Cough
AND
3.3 SpO2 between 90% and 93% on room air
AND
3.4 Respiratory Rate more or equal to 24 and less than 30 breaths per minute
Patients presenting to the hospital without a laboratory confirmed SARS-CoV-2 infection will be
tested locally for SARS-CoV-2 during the screening period.
For sites in the EU: A CE certified SARS-CoV-2 PCR test kit is required to confirm infection.
For sites outside the EU: SARS-CoV-2 PCR test kits certified according to local regulations are
required to confirm infection.
Weight
4. Body weight at least 50 kg and have a body mass index (BMI) ≥ 18.0 kg/m2 and < 40.0 kg/m2.
5. Male or female.
Pregnancy and Contraception
Contraceptive use by women and men should be consistent with local regulations regarding the
methods of contraception for those participating in clinical studies.
6. A female study participant is eligible to participate if she is not pregnant or breastfeeding,
and one of the following conditions applies:
a. She is not a WOCBP as defined in Section 10.3.1.
b. Is a WOCBP and is using a contraceptive method that is highly effective, with a
failure rate of <1%, as described in Section 10.3.2 during the IMP period and for at
least 4 weeks after the last dose of IMP. The investigator should evaluate the
potential for contraceptive method failure (e.g., noncompliance, recently initiated) in
relationship to the first dose of IMP.
7. A WOCBP must have a negative urine pregnancy test within 24 hours before the first dose of
IMP, see Section 8.3.5.
a. If a urine pregnancy test cannot be confirmed as negative (e.g., an ambiguous result),
a serum pregnancy test is required locally. In such cases, the participant must not be
randomized if the serum pregnancy result is positive.
b. If a serum pregnancy test is required as per local regulations, a serum pregnancy test
is required locally. In such cases, the participant must not be randomized if the serum
pregnancy result is positive.
c. The investigator is responsible for review of medical history, menstrual history, and
recent sexual activity to decrease the risk for inclusion of a woman with an early
undetectable pregnancy.
8. A male study participant is eligible to participate if:
a. He is azoospermic
b. The partner is not a WOCBP as defined in Section 10.3.1.
c. The partner is a WOCBP and is using a contraceptive method that is highly effective,
with a failure rate of <1%, as described in Section 10.3.2 during the IMP period and
for at least 90 days after the last dose of IMP. The investigator should evaluate the
potential for contraceptive method failure (e.g., noncompliance, recently initiated) in
relationship to the first dose of IMP.
d. He acknowledges that sperm donation is prohibited from the first dose of IMP until
at least 90 days after the last dose of IMP. 
 
ExclusionCriteria 
Details  1. Patient’s clinical condition is worsening rapidly.
2. Requiring ICU admission or ventilator support at screening or at randomization.
Suspected bacterial, fungal, viral, or other infection (besides COVID-19).
4. History of any of the following: malignant disease, autoimmune disease, or severe liver,
kidney, blood, cardiac, pulmonary, neurological, or endocrine disease as judged by the
investigator. The medical monitor should be contacted by the investigator.
5.1 Patients with uncontrolled hypertension (BP ≥ 140/90 mmHg).
6. Clinically significant cardiac conduction abnormalities, including QTc prolongation of >
450 milliseconds.
7. Family history of Long QT Syndrome.
8. Heart failure class 3, or 4, as defined by the New York Heart Association (NYHA).
9.1 History of acute coronary syndrome (including myocardial infarction), coronary angioplasty,
stenting, or thromboembolic event within 24 weeks prior to screening.
10. Patients with implanted defibrillators or permanent pacemakers.
11. Poorly controlled diabetes mellitus with an HbA1c > 7.5 %.
12. Renal disease including glomerulonephritis, nephritic syndrome, Fanconi Syndrome, or
renal tubular acidosis.
13. Renal failure requiring renal replacement therapy or moderate renal impairment as defined
by having an estimated glomerular filtration rate (eGFR, CKD-EPI) < 45 ml/min/1.73m2.
14. Chronic Obstructive Pulmonary Disease (COPD) GOLD C, or D, or hospitalization for
exacerbation of COPD within 24 weeks prior to screening.
15. Other chronic lung diseases including cystic fibrosis, neuromuscular diseases, severe chest
wall deformities, interstitial lung diseases, outpatient chronic non-invasive ventilation due to
chronic respiratory failure.
16. Asthma with a symptom control level of "uncontrolled", according to current GINA
guidelines.
17. Currently suffering from diseases that seriously affect the immune system, such as: human
immunodeficiency virus (HIV) infection, or the blood system, or splenectomy, or organ/
stem cell transplantation.
18. Known Hepatitis B or C infection.
19. Any medical condition, physical examination finding or laboratory abnormality that, in the
opinion of the investigator, might confound the results of the study or pose an additional risk
to the patient.
20. Alanine transaminase (ALT) or aspartate transaminase (AST) >3.0 x ULN.
21. Total bilirubin >1.0 x ULN (≥1.5 x ULN total bilirubin if known Gilbert’s syndrome).
Prior/Concomitant Therapy
22. Taking concomitant medication metabolized by CYP2C8 and/ or CYP2C9 and listed as
“prohibited” in Section 10.5.
23. Taking concomitant medication of any experimental treatment or use of marketed
medications including off-label use, that are intended as specific treatment for COVID19.
Any such treatments must be washed out for 30 days or at least 5 half-lives prior to
randomization, whichever is longer, unless a formal written standard of care policy document requires otherwise. Inclusion needs to be approved by the investigator and
medical monitor.
Taking medication that may seriously affect the immune system, e.g., chemotherapy, unless
considered and documented as standard of care (e.g., corticosteroids) to treat COVID-19.
Prior/Concurrent Clinical Study Experience
25. Currently participating in other clinical trials or previous treatment with an investigational
medicinal product within 5 half-lives or 30 days (whichever is longer) prior to
randomization.
Other Exclusions
26. Known allergy or hypersensitivity to the IMP (including excipients).
27. Study participant is pregnant or breastfeeding.
28. Patient has been committed to an institution by virtue of an order issued either by the
judicial or the administrative authorities.
29. Patient is an employee of the sponsor, or an employee of any third-party organization
involved into the clinical trial, or an employee of the clinical trial site, or is dependent on the
investigator.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical severity status on a 7 point ordinal scale at Day 15
Time from randomization to discharge from hospital
Time to discharge from hospital or to score of ≤2 maintained for 24 hours in NEWS2 whichever occurs first
Time to resolution of fever defined as ≤36.6°C (axilla) ≤37.2°C (oral) or ≤37.8°C (rectal or tympanic) for at least 24 hours without antipyretics for 24 hours.
Time to SpO2 94% on room air maintained for 24 hours
 		 Day 15 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical severity status on a 7 point ordinal scale at Day 15
Time from randomization to discharge from hospital
Time to discharge from hospital or to score of ≤2 maintained for 24 hours in NEWS2 whichever occurs first
Time to resolution of fever defined as ≤36.6°C (axilla) ≤37.2°C (oral) or ≤37.8°C (rectal or tympanic) for at least 24 hours without antipyretics for 24 hours.
Time to SpO2 94% on room air maintained for 24 hours
 		 Day 3, 5, 8, 11, 15, 30 
 
Target Sample Size   Total Sample Size="220"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   10/06/2021 
Date of Study Completion (India) 09/08/2022 
Date of First Enrollment (Global)  12/04/2021 
Date of Study Completion (Global) 09/08/2022 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   S. Ludwig, Targeting cell signalling pathways to fight the flu: towards a paradigm change in anti-influenza therapy. J Antimicrob Chemother 64, 1-4 (2009). 10. K. Droebner, S. Pleschka, S. Ludwig, O. Planz, Antiviral activity of the MEK inhibitor U0126 against pandemic H1N1v and highly pathogenic avian influenza virus in vitro and in vivo. Antiviral Res 92, 195-203 (2011).  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is a Phase 2, multi-center, randomized, double-blind, controlled, parallel group, two-arm clinical trial (ATR-002 vs. placebo). The study will assess the efficacy and safety of ATR-002 versus a matching placebo, as well as pharmacokinetics of ATR-002 in adult hospitalized patients with COVID-19. Study participants will additionally receive throughout the clinical trial any treatment that is considered standard of care as per local standards. To minimize bias, the clinical trial will be randomized and double-blind. Following screening procedures, eligible study participants will be centrally assigned to randomized investigational medicinal product (IMP) using Interactive Response Technology (IRT). The control group will receive matching placebo to the treatment (ATR-002) group. Drug concentration information will not be reported to study sites or blinded study personnel until the clinical trial has been unblinded. An independent Data Monitoring Committee will convene in accordance with clinical trial progress, i.e. after 20 study participants have been treated and then again after each 50 study participants have been treated. In addition, special meetings can take place if concerns about the safety of study participants arise. The clinical trial comprises a screening period of up to approximately 24 hours (on Day –1), followed by a 6-day treatment period on Days 1 to 6, and follow-up at defined time points up to Day 90.
Study participants will receive IMP (ATR-002 or placebo) orally once daily for 6 days. The daily dose of ATR-002 will be 900 mg on Day 1 and 600 mg on Days 2 to 6.
 
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