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Protocol Details

A Multicenter, Multi-Outbreak, Randomized, Controlled Safety and Efficacy Study of Investigational Therapeutics for the Treatment of Patients with Ebola Virus Disease

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

19-I-0003

Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 0
Max Age: 99

Referral Letter Required

Yes

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

EBOV;
Viral Hemorrhagic Fever;
Ebola Treatment Center;
Filovirus;
Zaire Ebola Virus

Recruitment Keyword(s)

None

Condition(s)

Ebola Virus

Investigational Drug(s)

MAb114
REGN-EB3

Investigational Device(s)

None

Intervention(s)

Drug: ZMapp
Drug: Remdesivir
Drug: MAb114
Drug: REGN-EB3

Supporting Site

National Institute of Allergy and Infectious Diseases

Background:

Ebola virus can cause serious illness or death. No medicines are approved to treat it. Researchers need to test new medicines to see if they help people recover from Ebola and are safe to give. They need to test the drugs and compare them in a controlled way. Researchers want to test 4 drugs with people who have Ebola and are in treatment centers.

Objective:

To study the safety and effectiveness of 4 drugs for people with Ebola virus.

Eligibility:

People of any age with Ebola infection who are in treatment centers

Design:

Participants will be screened with questions, medical history, and blood tests.

Participants will be randomly assigned to get 1 of 3 study drugs:

-ZMapp by IV over about 4 hours. It will be given 3 times, 3 days apart.

-Remdesivir by IV over about 1 hour. It will be given once a day for 10 days.

-Mab114 by IV for 30-60 minutes. It will be given 1 time.

-REGN-EB3 by IV for about 2 hours. It will be given 1 time.

For at least a week, participants will stay in isolation in a clinic. They will:

-Get supportive care and be monitored

-Have a small plastic tube (IV) put in an arm vein for several days to give fluids and collect blood.

-Get their study drug.

-Be monitored for disease signs and drug side effects. They may get medicines for side effects.

-Have blood and urine tests.

Participants will stay in the clinic until they finish the study drug and are well enough to leave.

Participants will have 2 follow-up visits over 2 months. They will answer questions and give blood and semen samples.

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Eligibility

INCLUSION CRITERIA:

-Males or females of any age with documented positive RT-PCR in blood for acute Ebola virus infection within 3 days prior to enrollment and who have symptoms of any duration.

-Willingness of study participant to accept randomization to any assigned treatment arm.

-All males and females of childbearing potential must be willing to use effective methods of contraception, from time of enrollment until Day 58 of study.

-Must agree not to enroll in another study of an investigational agent prior to completion of Day 28 of study.

-Ability to provide informed consent personally, or by a legally acceptable representative if the patient is unable to do so.

EXCLUSION CRITIERA:

-Patients who, in the judgment of the investigator, will be unlikely or unable to comply with the requirements of this protocol through Day 28.

-Prior treatment with any investigational antiviral drug therapy against Ebola virus infection within 5 half-lives or 30 days, whichever is longer, prior to enrollment. (Patients who have received an experimental (or, in future, potentially a licensed) immunization against Ebola virus remain eligible.)


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Richard T. Davey Jr., M.D.
National Institute of Allergy and Infectious Diseases (NIAID)



Richard T. Davey Jr., M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
BG 10-CRC RM 4-1479
10 CENTER DR
BETHESDA MD 20814
(301) 496-8029
rdavey@niaid.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT03719586

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