Clinical trial NCT05122182: Controlled Trial of Angiotensin Receptor Blocker (ARB) & Chemokine Receptor Type 2 (CCR2) Antagonist for the Treatment of COVID-19
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: COVID-19
SARS-CoV2 Infection
Keywords: COVID-19
SARS-CoV2
Angiotensin Receptor Blocker (ARB)
C-C chemokine receptor type 2 (CCR2) antagonist
Lead sponsor: University of Sydney
Sponsor class: OTHER
Collaborators: name: The George Institute
First posted: 2021-11-16
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Adults aged ≥ 18 years (maximum 65 years old in India).
2. 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)
3. Intended for hospital admission for management of COVID-19.
4. 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.
5. Systolic Blood Pressure (SBP) ≥ 120 mmHg OR SBP ≥ 115 mmHg and currently treated with a non-RAASi BP lowering agent that can be ceased.
6. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
7. Documented informed consent.

Exclusion Criteria:

1. Currently treated with an ACEi, ARB or aldosterone antagonist, aliskiren, or ARNi
2. Intolerance of ARBs
3. Serum potassium \>5.5 mmol/L
4. An estimated Glomerular Filtration Rate (eGFR) \<30ml/min/1.732m
5. Known biliary obstruction, known severe hepatic impairment (Child-Pugh-Turcotte score 10-15)
6. Pregnancy, lactation, or inadequate contraception.
7. Participation in a study of a novel investigational product within 28 days prior to randomisation.
8. Plans to participate in another study of a novel investigational product during this study.

Primary outcomes:
measure: Clinical Health Score at day 14
timeFrame: 14 days
Secondary outcomes:
measure: Clinical Health Score at day 28
timeFrame: 28 days
measure: ICU admission
timeFrame: 28 days
measure: Death
timeFrame: 28 days
measure: Time to death
timeFrame: 28 days
measure: Acute Kidney Injury
timeFrame: 28 days
measure: Respiratory Failure
timeFrame: 28 days
measure: Length of hospital admission
timeFrame: 28 days
measure: Length of ICU Admission
timeFrame: 28 days
measure: Requirement of ventilatory support
timeFrame: 28 days
measure: Requirement of dialysis
timeFrame: 28 days
measure: Clinical Health Score at day 60
timeFrame: 60 days
measure: Clinical Health Score at day 90
timeFrame: 90 days
measure: Clinical Health Score at day 180
timeFrame: 180 days
Other outcomes:
measure: Incidence of Hypotension
timeFrame: 28 days
measure: Incidence of Hyperkalemia
timeFrame: 28 days
measure: Incidence of Deranged Liver Function Tests
timeFrame: 28 days
measure: Total Serious Adverse Events (SAEs)
timeFrame: 28 days
measure: Incidence of hospital readmission
timeFrame: 90 days
Locations:
city: Aligarh
country: India
facility: Jawaharlal Nehru Medical College and Hospital
city: Chandigarh
country: India
facility: Government Medical College and Hospital
city: Guntur
country: India
facility: Samishta Hospital and Research Institute
city: Jaipur
country: India
facility: Maharaja Agrasen Hospital
city: Kochi
country: India
facility: Amrita Institute of Medical Science
city: Mangaluru
country: India
facility: Kasturba Medical College
city: Meppadi
country: India
facility: DM Wayanad Institute of Medical Sciences
city: Nigdi
country: India
facility: Sterling Hospital
city: Pune
country: India
facility: Jivanrekha Multi-Speciality Hospital
city: Raipur
country: India
facility: All India Institute of Medical Sciences, Raipur
Study officials:
affiliation: NHMRC Clinical Trials Centre, The University of Sydney
name: Meg Jardine
role: STUDY_CHAIR
affiliation: The George Institute
name: Vivekanand Jha
role: STUDY_CHAIR
References: