Compassionate Use of Opaganib in Patients With Coronavirus Disease 2019 (COVID-19)

NCT04435106 | Completed

• 1 other identifier: 0123-20- SZMC
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Shaare-Zedek Medical Center is a tertiary academic hospital in Jerusalem, Israel. On March 2020, a dramatic increase in the number of COVID-19 cases were diagnosed in Jerusalem. RedHill Biopharma, Ltd. offered opaganib under compassionate use for the treatment of COVID-19 patients. Eligible patients were those hospitalized with COVID-19 confirmed by a reverse-transcriptase-polymerase-chain-reaction assay. Patients received opaganib and Standard of Care. For the purpose of this study, the opaganib and Standard of Care patient group was compared to a group of patients that received only Standard of Care. Opaganib is an investigational drug under development and not approved for commercial distribution.

Conditions

Coronavirus Infections

Outcome Measures

Primary Outcomes (2)

• Measure the time to weaning from high-flow nasal cannula

  Every day from day 1 to day 14

• Measure the time to breathing ambient (room) air

  Every day from day 1 to day 14

Secondary Outcomes (2)

• Measure change in lymphocyte count

  On day of admission or day 1 of treatment and every 2-4 days, till day 14

• Measure change in C-reactive protein

  On day of admission or day 1 of treatment and every 2-4 days, till day 14

Study Arms (2)

Opaganib + Standard of Care

Study participants received opaganib 2 x 250 mg capsules (500 mg) every 12 hours in addition to Standard of Care

Drug: Opaganib; Drug: Standard of Care

Standard of Care

Study participants received Standard of Care

Drug: Standard of Care

Interventions

Opaganib DRUG

Study participants received opaganib 2 x 250 mg capsules (500 mg) every 12 hours in addition to Standard of Care

Also known as: Yeliva, ABC294640

Opaganib + Standard of Care

Standard of Care DRUG

Study participants received Standard of Care

Opaganib + Standard of Care; Standard of Care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with severe COVID-19 who required oxygen support via high-flow nasal cannula (HFNC)

You may qualify if:

• hospitalized patients with COVID-19 confirmed by a reverse-transcriptase-polymerase-chain-reaction assay
• patients with severe disease requiring oxygen support via high-flow nasal cannula
• signed informed consent
• acceptable liver and renal function tests
• acceptable hematologic status

You may not qualify if:

• pregnant or nursing women
• patients on warfarin, apixaban, argatroban or rivaroxaban
• patients with New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Shaare-Zedek Medical Center

Jerusalem, 9103102, Israel

Location

MeSH Terms

Conditions

Coronavirus Infections

Interventions

3-(4-chlorophenyl)-adamantane-1-carboxylic acid (pyridin-4-ylmethyl)amide; Standard of Care

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 17, 2020
• Study Start: April 3, 2020
• Primary Completion: May 1, 2020
• Study Completion: May 15, 2020
• Last Updated: June 17, 2020

Record last verified: 2020-06

Locations

IL (1)