Study of Monoclonal Antibodies for Early Etiotropic Therapy for Coronavirus Infection Caused by the SARS-CoV-2 Virus

NCT05729360 | Unknown Phase 2

• 1 other identifier: 02-GamCoviMab-2022
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Open prospective non-comparative study of safety and tolerability of the drug (GamCoviMab) with the description of the parameters of the therapeutic efficacy in patients with confirmed COVID-19 diagnosis.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• Occurrence of adverse events (AE)

  Occurrence of adverse events (AE) within 28 days after administration of the drug

  within 28 days after administration of the drug

• Occurrence of serious adverse events (SAEs)

  Occurrence of serious adverse events (SAEs) throughout the study

  within 180 days after administration of the drug

Study Arms (1)

Patients with a verified diagnosis of COVID-19

EXPERIMENTAL

Drug: GamCoviMab

Interventions

GamCoviMab DRUG

A total of 30 people will be randomized and receive the study drug (GamCoviMab) in a hospital setting (7 days of hospitalization).

Patients with a verified diagnosis of COVID-19

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of a written Informed Consent to participate in the study;
• Men and women aged 18 to 75 years inclusive;
• Positive SARS-CoV-2 test result ≤5 days prior to enrollment or clinical manifestations later confirmed by PCR;
• At the time of screening for the study, the patient is not hospitalized;
• Presence of high risk factors for severe COVID-19 and/or hospitalization and/or death, in the opinion of the investigator, not limited to the following:
• not fully vaccinated and unvaccinated patients
• elderly patients (over 60), including those with additional risk factors
• obesity
• immunocompromised patients, including those receiving immunosuppressive drugs for any indication
• with comorbidities (diabetes, diseases of the cardiovascular system, coagulopathy, chronic kidney disease, including conditions requiring dialysis, chronic lung disease, liver disease, etc.)
• Consent to use effective methods of contraception during the entire period of participation in the study.
• Able to carry out study visits.

You may not qualify if:

• The patient will not be included in the study in the following cases:
• Inability to read Russian; inability or unwillingness to understand the essence of the study. Any other condition that limits the eligibility of obtaining informed consent or may affect the volunteer's ability to participate in the study;
• Pregnancy or breast-feeding;
• Severe and extremely severe course of COVID-19:
• Oxygen saturation at rest according to pulse oximetry (SpO2) ≤ 93% OR
• PaO2/FiO2 ≤ 300 mm Hg OR
• Respiratory failure and need for invasive mechanical ventilation (with tracheal intubation) or ECMO OR
• Septic shock OR
• Multiple organ failure
• Prior therapy with plasma from a recovered COVID-19 patient or other anti-SARS CoV-2 mAbs for the treatment of current COVID-19 disease at study entry;
• The patient is currently hospitalized or, in the opinion of the investigator, may require hospitalization within the next 24 hours;
• Requires oxygen therapy due to COVID-19 disease or requires an increase in basal oxygen flow due to COVID-19 disease in individuals on chronic oxygen therapy due to non-COVID-19 related comorbidities;
• Confirmed active tuberculosis, AIDS;
• Body weight less than 40 kg;
• Volunteer participation in any other clinical trial within the last 90 days;

Sponsors & Collaborators

• Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation: lead

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 15, 2023
• Study Start: March 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 15, 2023

Record last verified: 2023-02