Covid19Phase 2NCT04840459
Use of Monoclonal Antibodies for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting
A Phase 2 study testing BAMLANIVIMAB, CASIRIVIMAB and IMDEVIMAB in people with Covid19, run by Sohail Rao at 3 sites in United States.
Trial summary
No therapeutic agent is currently approved for the treatment of SARSCoV-2 infection. More importantly, no intervention is currently available to mitigate the progression of disease from mid/moderate to serve particularly in high risk patients. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- BAMLANIVIMAB, CASIRIVIMAB and IMDEVIMAB
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Nov 2020to 31 Jan 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing
- 12 years of age and older weighing at least 40 kg
- are at ":high risk" for progressing to severe COVID-19 and/or hospitalization
- High risk is defined as patients who meet at least one of the following criteria:
- Have a body mass index (BMI) >35
- Have chronic kidney disease
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- Have diabetes
- Have immunosuppressive disease
- Are currently receiving immunosuppressive treatment
- Are over 65 years of age
- Are over 55 years of age AND have: cardiovascular disease, OR hypertension, OR chronic obstructive pulmonary disease/other chronic respiratory disease
- Are 12 - 17 years of age AND have
- BMI >85th percentile for their age and gender based on CDC o growth charts, ii. sickle cell disease OR iii. congenital or acquired heart disease OR iv. neurodevelopmental disorders, for example, cerebral palsy, OR a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19), OR
- asthma, reactive airway or other chronic respiratory disease o that requires daily medication for control.
Who cannot join
- Younger than 12 years of age
- Do not meet criteria to be classified as "high risk'
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
DHR Health Institute for Research and Development
Edinburg, Texas, 78539
Sohail Rao, MD, 956-362-2387, s.rao@dhr-rgv.com
Monica Betancourt-Garcia, MD, 9563623223, m.betancourt@dhr-rgv.com
- Recruiting
DHR Health
Edinburg, Texas, 78539
Sohail Rao, MD, 956-362-2387, s.rao@dhr-rgv.com
Monica Garcia-Betancourt, MD, 9563623223, m.betancourt@dhr-rgv.com
- Recruiting
Starr County Memorial Hospital
Rio Grande City, Texas, 78582
Sohail Rao, MD, 956-362-2387, s.rao@dhr-rgv.com
Monica Garcia-Betancourt, MD, 9563623223, m.betancourt@dhr-rgv.com
About this study
Official title: Use of Monoclonal Antibodies (Bamlanivimab and Casirivimab + Imdevimab) for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting
No therapeutic agent is currently approved for the treatment of SARSCoV-2 infection. More importantly, no intervention is currently available to mitigate the progression of disease from mid/moderate to serve particularly in high risk patients. Recognizing this limitation and urgency of finding a treatment for COVID-19, the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergencyuse of the unapproved product bamlanivimab or casirivimab + imdevimab for the treatment of mild to moderate coronavirus disease 2019 (COVID19) in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
- Conditions
- Covid19
- Being tested
- BAMLANIVIMAB, CASIRIVIMAB, IMDEVIMAB
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAMLANIVIMABBiological
- Bamlanivimab is a recombinant neutralizing human mIgG1? monoclonal antibody (mAb) to the spike protein of SARS-CoV-2, and is unmodified in the Fc region.
CASIRIVIMABBiological
CASIRIVIMAB is a recombinant human mAbs which are unmodified in the Fc regions.
IMDEVIMABBiological
IMDEVIMAB is a recombinant human mAbs which are unmodified in the Fc regions.
| Study group | Role | What they receive |
|---|---|---|
| BAMLANIVIMAB | Experimental | The dosage of bamlanivimab in adults and pediatric patients 12 years of age and older weighing at least 40 kg is a single IV infusion of 700 mg bamlanivimab administered over at least 60 minutes Receives: Biological: BAMLANIVIMAB |
| CASIRIVIMAB + IMDEVIMAB | Experimental | 10 mL of casirivimab and 10 mL of imdevimab from each respective vial using two separate syringes and dilute together in the infusion bag containing 0.9% Sodium Chloride Injection Receives: Biological: CASIRIVIMAB; Biological: IMDEVIMAB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimize and/or eliminate the number of patients with mild to moderate COVID-19 who are at high risk for progressing to severe COVID-19 and/or hospitalization.
Will record the number of participants who are prevented from progressing to sever infection.
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start20 Nov 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohail Rao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sohail Rao, DHR Health Institute for Research and Development
- Investigators
- Sohail Rao, MD, Principal investigator, DHR Heath Institute for Research and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840459
- Sponsor's protocol ID
- 1686206
- Status last verified
- Mar 2022
- First submitted
- 5 Apr 2021
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Monoclonal Antibodies (Bamlanivimab and Casirivimab + Imdevimab) for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting
- ClinicalTrials.gov ID
- NCT04840459
- Acronym / sponsor ID
- 1686206
- Conditions
- Covid19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Sohail RaoUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 12 Apr 2021 (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.
No therapeutic agent is currently approved for the treatment of SARSCoV-2 infection. More importantly, no intervention is currently available to mitigate the progression of disease from mid/moderate to serve particularly in high risk patients. Recognizing this limitation and urgency of finding a treatment for COVID-19, the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergencyuse of the unapproved product bamlanivimab or casirivimab + imdevimab for the treatment of mild to moderate coronavirus disease 2019 (COVID19) in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAMLANIVIMAB | Experimental | Biological: BAMLANIVIMABThe dosage of bamlanivimab in adults and pediatric patients 12 years of age and older weighing at least 40 kg is a single IV infusion of 700 mg bamlanivimab administered over at least 60 minutes |
| CASIRIVIMAB + IMDEVIMAB | Experimental | Biological: CASIRIVIMAB, Biological: IMDEVIMAB10 mL of casirivimab and 10 mL of imdevimab from each respective vial using two separate syringes and dilute together in the infusion bag containing 0.9% Sodium Chloride Injection |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing
- 12 years of age and older weighing at least 40 kg
- are at ":high risk" for progressing to severe COVID-19 and/or hospitalization
- Have a body mass index (BMI) >35
- Have chronic kidney disease
Key exclusion criteria (2 listed)
- Younger than 12 years of age
- Do not meet criteria to be classified as "high risk'
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 |
|---|---|---|
| BAMLANIVIMABn. Bamlanivimab is a recombinant neutralizing human mIgG1? monoclonal antibody (mAb) to the spike protein of SARS-CoV-2, and is unmodified in the Fc region. | Biological | BAMLANIVIMAB |
| CASIRIVIMABCASIRIVIMAB is a recombinant human mAbs which are unmodified in the Fc regions. | Biological | CASIRIVIMAB + IMDEVIMAB |
| IMDEVIMABIMDEVIMAB is a recombinant human mAbs which are unmodified in the Fc regions. | Biological | CASIRIVIMAB + IMDEVIMAB |
Primary outcome
Minimize and/or eliminate the number of patients with mild to moderate COVID-19 who are at high risk for progressing to severe COVID-19 and/or hospitalization.
Time frame: two weeks
Will record the number of participants who are prevented from progressing to sever infection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Sohail Rao, MD principal investigator
DHR Heath Institute for Research and Development
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BAMLANIVIMAB, CASIRIVIMAB and IMDEVIMAB in people with Covid19, run by Sohail Rao at 3 sites in United States.
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 14 inclusion and 2 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 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Sohail Rao, MD (9563622387, s.rao@dhr-rgv.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimize and/or eliminate the number of patients with mild to moderate COVID-19 who are at high risk for progressing to severe COVID-19 and/or hospitalization. (time frame: two weeks). 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 29 Mar 2022.