A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Patients with COVID-19

Purpose

To evaluate the virologic efficacy of REGN10933+REGN10987 and REGN10989 compared toplacebo in reducing viral shedding of SARS-CoV-2.

Criteria

Criteria:  

At least 18 years old

Positive Covid test (nasal swab) within 72 hours; this can be repeated if necessary

Experiencing at least one of the following symptoms:

Fever, cough, shortness of breath

Has symptoms consistent with COVID-19, with onset ≤7 days

You Cannot:

Can not gave been admitted to a hospital or be in hospital(inpatient) at randomization, due to COVID-19

Can not gave participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, mAbs against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit

Can not have a history of COVID-19 investigational or Emergency Use Authorization (EUA)-approved treatments in the past 30 days or less than 5 half-lives of the nvestigational product (whichever is longer) prior to the screening visit. This includes, but is not limited to: remdesivir, hydroxychloroquine, tocilizumab, sarilumab, and other immunomodulatory agents

Can not currently use any COVID-19 investigational or EUA-approved treatment

Can not require IVIG for medical condition other than COVID-19

Can not be pregnant or breastfeeding women

Details

NP swabs will be collected every other day for the first 2 weeks and then approximately twice weekly thereafter.

No cost to the patient or insurance

Free Covid-19 testing / treatment

Patient stipend  

Single infusion

Interested in more information? Contact Us:

Clint Wilson, M.D., Principal Investigator
(318) 212-8130

IRB: WIRB
IRB Number:
Trial Type: NA
Sponsor: Regeneron