Clazakizumab vs. Placebo - COVID-19 Infection

Part of paid clinical trials in Houston, Texas.

Sponsor
The Methodist Hospital Research Institute
Study ID
NCT04494724
Phase
PHASE2
Status
Unknown

Conditions

  • COVID-19 Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to investigate the effectiveness and safety of treatment with clazakizumab compared to a placebo (inactive substance). We are proposing to try this drug to treat coronavirus disease 2019 (COVID-19) infection. Patients with COVID-19 infection have been shown to have increases in certain inflammatory processes. Clazakizumab is an antibody (immune system protein) that blocks certain inflammatory processes. The treatment plan is to attempt to inhibit or block these inflammatory processes in order to try to limit the damage COVID-19 causes to the lungs.

Key Dates

Start date
Jul 13, 2020
Status verified
Jul 2020
Primary completion
Dec 31, 2020
Completion
Jul 31, 2021

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Clazakizumab
    Clazakizumab - 25mg in 50 milliliters (mL) of 0.9% saline, IV infusion over 30 minutes.
  • Placebo Comparator: Placebo
    Placebo - 50 mL 0.9% saline, IV infusion over 30 minutes.

Primary Outcome Measure

Primary Endpoint [ Time Frame: 24 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Houston Methodist HospitalHoustonTexas77030
Isioma Agboli, MD
[email protected]
713-441-6311
Darrel Cleere, BSN
[email protected]
713-441-6232
Howard J Huang, MD (PRINCIPAL_INVESTIGATOR)
Alex Rogers, PharmD (SUB_INVESTIGATOR)
Ahmad Goodarzi, MD (SUB_INVESTIGATOR)
Yihad G Youssef, MD (SUB_INVESTIGATOR)
Simon Yau, MD (SUB_INVESTIGATOR)
Faisal Zahiruddin, MD (SUB_INVESTIGATOR)
Linda W Moore, PhD (SUB_INVESTIGATOR)
Ahmed O Gaber, MD (SUB_INVESTIGATOR)

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By research site
Houston Methodist Hospital· Houston, TX

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