COVID-19Phase 2NCT05729360
Study of Monoclonal Antibodies for Early Etiotropic Therapy for Coronavirus Infection Caused by the SARS-CoV-2 Virus
A Phase 2 study testing GamCoviMab in people with COVID-19, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID-19
- What is being tested?
- GamCoviMab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Each potential patient for inclusion in the study must meet all of the following criteria:
- 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;
- Oxygen saturation ≥93% without oxygen donation by any means, diagnosed with COVID-19 disease with symptom onset within 5 days of inclusion;
- Presence of several symptoms of mild or moderate severity at the time of inclusion in the study;
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- 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.
Who cannot join
- 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
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- 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;
- The presence of any life-threatening decompensated comorbidity which, in the opinion of the Investigator, makes the patient unsuitable for inclusion in the study;
- Body weight less than 40 kg;
- Volunteer participation in any other clinical trial within the last 90 days;
- Requires mechanical ventilation or the inevitable need for mechanical ventilation in the next 24 hours based on the current state of the patient;
- Suspected or proven serious active bacterial, fungal, viral, or other infection (other than COVID-19) that, in the opinion of the investigator, may pose a risk to the volunteer and affect the assessment of study endpoints;
- There are concomitant diseases requiring surgical intervention within the next month;
- Aggravated allergic history (including, but not limited to, erythema multiforme major, toxic epidermal necrolysis, Quincke's edema, polymorphic exudative eczema, a history of serum sickness, hypersensitivity or allergic reactions to the administration of immunobiological drugs, known allergic reactions to drug components, etc.);
- Severe infusion reactions in history;
- Alcohol or drug addiction.
About this study
Official title: "An Open Safety Study and Description of the Parameters of the Therapeutic Efficacy of the Drug for Early Etiotropic Therapy for Coronavirus Infection Caused by the SARS-CoV-2 Virus, With a Single Application in Patients With Confirmed COVID-19 Diagnosis"
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
- Being tested
- GamCoviMab
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GamCoviMabDrug
A total of 30 people will be randomized and receive the study drug (GamCoviMab) in a hospital setting (7 days of hospitalization).
| Study group | Role | What they receive |
|---|---|---|
| Patients with a verified diagnosis of COVID-19 | Experimental | Not described Receives: Drug: GamCoviMab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events (AE)
Occurrence of adverse events (AE) within 28 days after administration of the drug
Measured: within 28 days after administration of the drug
Occurrence of serious adverse events (SAEs)
Occurrence of serious adverse events (SAEs) throughout the study
Measured: within 180 days after administration of the drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study startMar 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729360
- Sponsor's protocol ID
- 02-GamCoviMab-2022
- Status last verified
- Feb 2023
- First submitted
- 6 Feb 2023
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "An Open Safety Study and Description of the Parameters of the Therapeutic Efficacy of the Drug for Early Etiotropic Therapy for Coronavirus Infection Caused by the SARS-CoV-2 Virus, With a Single Application in Patients With Confirmed COVID-19 Diagnosis"
- ClinicalTrials.gov ID
- NCT05729360
- Acronym / sponsor ID
- 02-GamCoviMab-2022
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a verified diagnosis of COVID-19 | Experimental | Drug: GamCoviMab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Each potential patient for inclusion in the study must meet all of the following criteria:
- 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;
- Oxygen saturation ≥93% without oxygen donation by any means, diagnosed with COVID-19 disease with symptom onset within 5 days of inclusion;
Key exclusion criteria (22 listed)
- 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:
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GamCoviMabA total of 30 people will be randomized and receive the study drug (GamCoviMab) in a hospital setting (7 days of hospitalization). | Drug | Patients with a verified diagnosis of COVID-19 |
Primary outcome
Occurrence of adverse events (AE)
Time frame: within 28 days after administration of the drug
Occurrence of adverse events (AE) within 28 days after administration of the drug
Occurrence of serious adverse events (SAEs)
Time frame: within 180 days after administration of the drug
Occurrence of serious adverse events (SAEs) throughout the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GamCoviMab in people with COVID-19, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of adverse events (AE) (time frame: within 28 days after administration of the drug). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.