Study Stopped
Withdrawal of funding support from the trial funder.
Controlled Trial of Angiotensin Receptor Blocker (ARB) & Chemokine Receptor Type 2 (CCR2) Antagonist for the Treatment of COVID-19
CLARITY 2
An Investigator Initiated, International Multi-Centre, Multi-Arm, Multi-Stage Randomised Double Blind Placebo Controlled Trial of Angiotensin Receptor Blocker (ARB) & Chemokine Receptor Type 2 (CCR2) Antagonist for the Treatment of COVID-19
1 other identifier
interventional
49
1 country
10
Brief Summary
CLARITY 2.0 is an investigator-initiated trial that will evaluate the safety and efficacy of dual treatment with repagermanium, a CCR2 antagonist, and candesartan, an ARB, in patients hospitalised with COVID-19 disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 covid19
Started Jan 2022
Typical duration for phase_2 covid19
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2021
CompletedFirst Posted
Study publicly available on registry
November 16, 2021
CompletedStudy Start
First participant enrolled
January 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 28, 2023
CompletedSeptember 15, 2023
September 1, 2023
7 months
November 14, 2021
September 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Health Score at day 14
The primary objective is to evaluate the safety and efficacy of dual treatment with repagermanium and candesartan in patients hospitalised with COVID-19 disease, assessed by the Clinical Health Score at day 14, which is determined within an 8-point ordinal scale of health status: 1. Not hospitalised, no limitations on activities. 2. Not hospitalised, limitation on activities. 3. Hospitalised, not requiring supplemental oxygen. 4. Hospitalised, requiring supplemental oxygen by mask or nasal prongs. 5. Hospitalised, on non-invasive ventilation or high-flow oxygen devices. 6. Hospitalised, requiring intubation and mechanical ventilation. 7. Hospitalised, on invasive mechanical ventilation and additional organ support (ECMO). 8. Death.
14 days
Secondary Outcomes (13)
Clinical Health Score at day 28
28 days
ICU admission
28 days
Death
28 days
Time to death
28 days
Acute Kidney Injury
28 days
- +8 more secondary outcomes
Other Outcomes (5)
Incidence of Hypotension
28 days
Incidence of Hyperkalemia
28 days
Incidence of Deranged Liver Function Tests
28 days
- +2 more other outcomes
Study Arms (3)
Interventional Arm
EXPERIMENTALTitratable candesartan with commencing dose 4mg tablets twice daily (daily dose 8 mg) + fixed dose repagermanium one x 120mg immediate release capsule twice daily (total daily dose 240mg). Treatment will continue for 28 days.
Control Arm #1
PLACEBO COMPARATORTitratable candesartan with commencing dose 4mg tablets twice daily (daily dose 8 mg) + matched placebo repagermanium one capsule twice daily. Treatment will continue for 28 days.
Control Arm #2
PLACEBO COMPARATORTitratable matched placebo candesartan one tablet twice daily + matched placebo repagermanium one capsule twice daily. Treatment will continue for 28 days.
Interventions
C-C chemokine receptor type 2 (CCR2) antagonist
C-C chemokine receptor type 2 (CCR2) antagonist placebo
Eligibility Criteria
You may qualify if:
- Adults aged ≥ 18 years (maximum 65 years old in India).
- Laboratory-confirmed diagnosis of SARS-CoV-2 infection within 10 days prior to randomisation. (Confirmation must be through Reverse Transcription Polymerase Chain Reaction \[RT-PCR\] method)
- Intended for hospital admission for management of COVID-19.
- Patients with moderate (respiratory rate of ≥ 24/minute or SPO2: 90% to ≤ 93% on room air) or severe (respiratory rate of ≥ 30/minute or SPO2: \<90% on room air) COVID-19.
- Systolic Blood Pressure (SBP) ≥ 120 mmHg OR SBP ≥ 115 mmHg and currently treated with a non-RAASi BP lowering agent that can be ceased.
- Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
- Documented informed consent.
You may not qualify if:
- Currently treated with an ACEi, ARB or aldosterone antagonist, aliskiren, or ARNi
- Intolerance of ARBs
- Serum potassium \>5.5 mmol/L
- An estimated Glomerular Filtration Rate (eGFR) \<30ml/min/1.732m
- Known biliary obstruction, known severe hepatic impairment (Child-Pugh-Turcotte score 10-15)
- Pregnancy, lactation, or inadequate contraception.
- Participation in a study of a novel investigational product within 28 days prior to randomisation.
- Plans to participate in another study of a novel investigational product during this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Sydneylead
- The George Institutecollaborator
Study Sites (10)
Jawaharlal Nehru Medical College and Hospital
Aligarh, India
Government Medical College and Hospital
Chandigarh, India
Samishta Hospital and Research Institute
Guntur, India
Maharaja Agrasen Hospital
Jaipur, India
Amrita Institute of Medical Science
Kochi, India
Kasturba Medical College
Mangaluru, India
DM Wayanad Institute of Medical Sciences
Meppādi, India
Sterling Hospital
Nigdi, India
Jivanrekha Multi-Speciality Hospital
Pune, India
All India Institute of Medical Sciences, Raipur
Raipur, India
Related Publications (1)
O'Hara DV, Bassi A, Wilcox A, Jha V, Rathore V, D'Cruz S, Snelling TL, Jones M, Totterdell J, Bangi A, Jain MK, Pollock C, Burrell L, Fox G, Jones C, Kotwal S, Faridah Syed Omar S, Jardine M; CLARITY 2.0 trial investigators. Combination of the chemokine receptor type 2 (CCR2) antagonist DMX-200 and candesartan for COVID-19: a randomised controlled trial. BMJ Open. 2024 Oct 22;14(10):e081790. doi: 10.1136/bmjopen-2023-081790.
PMID: 39438096DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Meg Jardine
NHMRC Clinical Trials Centre, The University of Sydney
- STUDY CHAIR
Vivekanand Jha
The George Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2021
First Posted
November 16, 2021
Study Start
January 7, 2022
Primary Completion
August 15, 2022
Study Completion
January 28, 2023
Last Updated
September 15, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
- Access Criteria
- Data will be available after publication for an indefinite time / for a finite time (specify dates) All data requests will be considered by the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement that the requester must agree to before access is granted. Access can be requested via the Health Data Australia catalogue
Trial data will be disseminated in the form of a publication to a relevant clinical journal and presentation at appropriate scientific conferences. Individual participant data that underlie the results reported, after de-identification (text, tables, figures, and appendices), may be shared with Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.