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

NCT04435106 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 23

Last updated 2020-06-17

No results posted yet for this study

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

Interventions

DRUG

Opaganib

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

DRUG

Standard of Care

Study participants received Standard of Care

Sponsors & Collaborators

  • Shaare Zedek Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-03
Primary Completion
2020-05-01
Completion
2020-05-15

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04435106 on ClinicalTrials.gov