SARS-CoV-2Phase 1NCT04592549
Study of Monoclonal Antibody Cocktail Being Tested for the Prevention of COVID-19
A Phase 1 study testing ADM03820 in people with SARS-CoV-2, run by Alachua Government Services, Inc. at 2 sites in United States.
Trial summary
This is a phase 1, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety, pharmacokinetics, and immunogenicity of ADM03820 administered as IM injections in healthy adults for the prevention of COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- ADM03820
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Dec 2020to 6 Oct 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent understood and signed
- Healthy male or healthy, non-pregnant, non-lactating female
- Willingness to comply and be available for all protocol procedures for the duration of the study
- Between the ages of 18 and 55, inclusive on the day of dosing
- Body Mass Index (BMI) of ≥18.5 and ≤35 kg/m2
- Female subjects of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test on Day 1 prior to dosing.
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- Note: A woman is considered of childbearing potential unless post-menopausal (> or = 1 year without menses without other known or suspected cause and appropriately elevated FSH) or surgically sterilized via bilateral oophorectomy or hysterectomy
- Females of childbearing potential and males agree to use acceptable contraception for the duration of the study
- Note: These include progestin implants, intrauterine devices (IUDs), surgical (hysterectomy or tubal ligation; vasectomy) or abstinence. Use of methods such as progestin injectables, combined oral hormonal contraceptives, condoms, and diaphragms will not be acceptable when used alone, but they could be considered, if used in combination with another method (for example, a female using combined oral contraceptives if her male partner is sterile, or if she and her non-sterile male partner use a double-barrier method), after consultation with the Ology Bioservices MM. All males will be required to use a barrier method (condoms) for the duration of the study
- Screening laboratory tests are within normal ranges or outside the normal ranges and considered not clinically significant by the Principal Investigator
- If urinalysis by dipstick is abnormal, a complete urinalysis with microscopic evaluation will be performed and the results will supersede the results of the dipstick for blood, glucose, and protein.
- Menstruating females failing inclusion criteria due to a positive blood on urine test may be retested following cessation of menses.
- Other laboratory values that are outside the range of eligibility but are thought to be due to an acute condition or collection or laboratory error may be repeated once.
- The urine drug screen is negative
- Breathalyzer test or blood/saliva alcohol test is negative and subject agrees to abstain from alcohol consumption for a period of 2 days prior to dosing and 2 days prior to any study visit.
- Agree to minimize risk of SARS-CoV-2 infection.
Who cannot join
- History of chronic medical condition that would either interfere with the accurate assessment of the objectives of the study or increase the risk profile of the subject.
- Subjects with cardiovascular disease
- Subjects with diabetes
- Subjects with pulmonary diseases such as COPD or asthma
- History of severe allergic reactions of any type to medications, bee stings, food, or environmental factors or hypersensitivity or reaction to immunoglobins.
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds)
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- Clinically significant abnormal electrocardiogram at screening.
- Note: Clinically significant abnormal ECG results include but not limited to:
- complete left or right bundle branch block; other ventricular conduction block; 2nd degree or 3rd degree atrioventricular (AV) block; sustained ventricular arrhythmia; sustained atrial arrhythmia; two Premature Ventricular Contractions in a row; pattern of ST elevation felt consistent with cardiac ischemia; or any condition deemed clinically significant by a study investigator
- Incomplete right bundle branch block is not exclusionary if there are no abnormal ECG findings and there is no clinical history or evidence on physical examination to indicate cardiac disease.
- Positive serology results for HIV, HBsAg, or HCV antibodies
- Febrile illness with temperature ≥38°C within 7 days of dosing
- Female subject who is pregnant or breastfeeding
- Donated blood within 56 days of enrollment
- Known allergic reactions to any of the study product components present in the formulation or in the processing, as listed in the Investigator Brochure
- Treatment with another investigational drug within 28 days of dosing
- Treatment with a monoclonal antibody within 3 months of enrollment
- Positive serology results for SARS-CoV-2 antibodies (Not applicable for Cohort 5).
- Positive results from a reverse transcriptase polymerase chain reaction (RT PCR) test for SARS CoV 2
- Receipt of antibody (e.g. TIG, VZIG, IVIG, IM gamma globulin) or blood transfusion within 6 months or within 5 half-lives of the specific product given
- Active drug or alcohol use disorder or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
- Use of H1 antihistamines or beta-blockers within 5 days of dosing
- Use of any prohibited medication within 28 days prior to screening or planned use during the study period
- Note: Prohibited medications include immunosuppressives (except Nonsteroidal Anti-Inflammatory Drugs [NSAIDS]); immune modulators; oral corticosteroids (topical/intranasal steroids are acceptable); anti-neoplastic agents
- Any specific condition that in the judgment of the investigator precludes participation because it could affect subject safety
- Plans to enroll or is already enrolled in another clinical trial that could interfere with safety assessment of the investigational product at any time during the study period
- Note: Includes trials that have a study intervention such as a drug, biologic, or device
- Is a study site employee or staff
- Note: Site employees or staff include the PIs and sub-investigators or staff who are supervised by the PI or Sub-Investigators
- Received an approved COVID-19 vaccine (subjects can receive an approved COVID-19 vaccine after completing their Day 90 visit). For Cohort 5, subjects who received a COVID-19 vaccine within 14 days prior to enrollment are excluded.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
ICON Early Phase Services, LLC
San Antonio, Texas, 78209
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Immunogenicity of ADM03820 in Adults
This is a phase 1, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety, pharmacokinetics, and immunogenicity of ADM03820 administered as IM injections in healthy adults for the prevention of COVID-19.
Read the detailed description
The primary objective of this study is to assess the safety and tolerability of escalating IM doses of ADM03820 in healthy adults. Secondary objectives include assessing the pharmacokinetic characteristics and immunogenicity.
- Conditions
- SARS-CoV-2
- Being tested
- ADM03820, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADM03820Drug
ADM03820 is a 1:1 mixture of two human IgG1 non-competitive binding anti-SARS-CoV-2 antibodies
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: 150 mg IM injection of active drug or placebo | Experimental | Subjects in cohort 1 will receive a 150 mg dose IM injection of either active drug or placebo.
Cohort 1 will dose 8 subjects to active drug and 2 subject to placebo Receives: Drug: ADM03820; Other: Placebo |
| Cohort 2: 300 mg IM injection of active drug or placebo | Experimental | Subjects in cohort 2 will receive 300 mg IM injection of either active drug or placebo.
Cohort 2 will dose 8 subjects to active drug and 2 subject to placebo. Receives: Drug: ADM03820; Other: Placebo |
| Cohort 3: 300 mg IM injection of active drug or placebo | Experimental | Subjects in cohort 3 will receive 300 mg IM injection of either active drug or placebo.
Cohort 3 will dose 8 subjects to active drug and 2 subject to placebo Receives: Drug: ADM03820; Other: Placebo |
| Cohort 4: 300 mg IM injection of active drug or placebo | Experimental | Subjects in cohort 4 will receive 300 mg IM injection of either active drug or placebo.
Cohort 4 will dose 8 subjects to active drug and 2 subject to placebo Receives: Drug: ADM03820; Other: Placebo |
| Cohort 5: 600 mg IM injection of active drug or placebo | Experimental | Subjects in cohort 5 will receive 600 mg IM injection of either active drug or placebo.
Cohort 5 will dose 8 subjects to active drug and 2 subject to placebo Receives: Drug: ADM03820; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants With Serious Adverse Events Following Administration of ADM03820 to the Final Visit
Determine number of SAEs after dosing through the final visit
Measured: 540 days for Cohorts 1-4, 365 days for Cohort 5, and up to 540 days for placebo
The Number of Participants With AEs Following Administration of ADM03820 to the Final Visit
Determine the number of AEs after dosing
Measured: 540 days for Cohorts 1-4, 365 days for Cohort 5, and up to 540 days for placebo
The Number of Participants With Changes From Baseline in Physical Examination, Vital Signs, and Clinical Safety Laboratory Values Following Administration of ADM03820 to the Final Visit
The number of participants that were includes in this data are those who had clinically significant physical examinations, vital signs, and clinical safety laboratory values following administration of ADM03820 to the final visit.
Measured: 540 days
Secondary outcomes (11)
The Assessment of Peak Plasma Concentration (Cmax) for Total Antibodies of ADM03820 as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Methods Designed for Total Monoclonal Antibody in the Drug Product (Cohorts 1-2).
Measured: pre-dose, 2, 4, 8, and 24 hours post-dose, and on Days 3, 4, 8, 15, 30, 45, 60, 90, 120, 150, 180, and 365
The Assessment of Tmax for Total Antibodies of ADM03820 as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Methods Designed for Total Monoclonal Antibody in the Drug Product (Cohorts 1-2).
Measured: pre-dose, 2, 4, 8, and 24 hours post-dose, and on Days 3, 4, 8, 15, 30, 45, 60, 90, 120, 150, 180, and 365
The Assessment of the Area Under the Plasma Concentration (AUC(0-t)) for the Total Antibodies of ADM03820 as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Methods Designed for Total Monoclonal Antibody in the Drug Product (Cohorts 1-2).
Measured: pre-dose, 2, 4, 8, and 24 hours post-dose, and on Days 3, 4, 8, 15, 30, 45, 60, 90, 120, 150, 180, and 365
The Assessment of Peak Plasma Concentration (Cmax) for Each of the Monoclonal Antibodies of ADM03820 as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Methods Designed for Total Monoclonal Antibody in the Drug Product (Cohorts 3-5).
Measured: pre-dose, 2, 4, 8, and 24 hours post-dose, and on Days 3, 4, 8, 15, 30, 45, 60, 90, 120, 150, 180, and 365
The Assessment of Tmax for Each of the Monoclonal Antibodies of ADM03820 as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Methods Designed for Total Monoclonal Antibody in the Drug Product (Cohorts 3-5).
Measured: pre-dose, 2, 4, 8, and 24 hours post-dose, and on Days 3, 4, 8, 15, 30, 45, 60, 90, 120, 150, 180, and 365
The Assessment of Area Under the Plasma Concentration (AUC(0-t)) for Each of the Monoclonal Antibodies of ADM03820 as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Methods Designed for Total Monoclonal Antibody in the Drug Product (Cohorts 3-5).
Measured: pre-dose, 2, 4, 8, and 24 hours post-dose, and on Days 3, 4, 8, 15, 30, 45, 60, 90, 120, 150, 180, and 365
Presence of Anti-drug Antibody (ADA) Levels
This outcome looks at the total number of participants who had ADA levels at each time point
Measured: pre-dose, and Day 15, 30, 45, 60, 90, 120, 150, and 180
The Number of Participants With SARS-CoV-2 RT-PCR Positive Symptomatic Illness Occurring After Dosing
Measured: 365 days
The Number of Participants With SARS-CoV-2 RT-PCR Positive Severe or Critical Symptomatic Illness Occurring After Dosing
Measured: 365 days
The Number of Participants With COVID-19 Related Emergency Department Visits Occurring After Dosing
Measured: 365 days
The Presence of Neutralizing Antibody Concentrations of ADM03820 as Measured by Microneutralization (MN) Methods
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start4 Dec 2020
- Primary completion6 Oct 2023
- Study completion6 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alachua Government Services, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Enabling Biotechnologies (EB)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592549
- Sponsor's protocol ID
- ADM03820-001
- Status last verified
- Feb 2025
- First submitted
- 12 Oct 2020
- Last updated
- 7 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PubMed 34473343
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Immunogenicity of ADM03820 in Adults
- ClinicalTrials.gov ID
- NCT04592549
- Acronym / sponsor ID
- ADM03820-001
- Conditions
- SARS-CoV-2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Alachua Government Services, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Enabling Biotechnologies (EB)
- Study start
- 4 Dec 2020 (actual)
- Primary completion
- 6 Oct 2023 (actual)
- Study completion
- 6 Oct 2023 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Posted 7 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety, pharmacokinetics, and immunogenicity of ADM03820 administered as IM injections in healthy adults for the prevention of COVID-19.
Detailed description
The primary objective of this study is to assess the safety and tolerability of escalating IM doses of ADM03820 in healthy adults. Secondary objectives include assessing the pharmacokinetic characteristics and immunogenicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: 150 mg IM injection of active drug or placebo | Experimental | Drug: ADM03820, Other: PlaceboSubjects in cohort 1 will receive a 150 mg dose IM injection of either active drug or placebo. Cohort 1 will dose 8 subjects to active drug and 2 subject to placebo |
| Cohort 2: 300 mg IM injection of active drug or placebo | Experimental | Drug: ADM03820, Other: PlaceboSubjects in cohort 2 will receive 300 mg IM injection of either active drug or placebo. Cohort 2 will dose 8 subjects to active drug and 2 subject to placebo. |
| Cohort 3: 300 mg IM injection of active drug or placebo | Experimental | Drug: ADM03820, Other: PlaceboSubjects in cohort 3 will receive 300 mg IM injection of either active drug or placebo. Cohort 3 will dose 8 subjects to active drug and 2 subject to placebo |
| Cohort 4: 300 mg IM injection of active drug or placebo | Experimental | Drug: ADM03820, Other: PlaceboSubjects in cohort 4 will receive 300 mg IM injection of either active drug or placebo. Cohort 4 will dose 8 subjects to active drug and 2 subject to placebo |
| Cohort 5: 600 mg IM injection of active drug or placebo | Experimental | Drug: ADM03820, Other: PlaceboSubjects in cohort 5 will receive 600 mg IM injection of either active drug or placebo. Cohort 5 will dose 8 subjects to active drug and 2 subject to placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Informed consent understood and signed
- Healthy male or healthy, non-pregnant, non-lactating female
- Willingness to comply and be available for all protocol procedures for the duration of the study
- Between the ages of 18 and 55, inclusive on the day of dosing
- Body Mass Index (BMI) of ≥18.5 and ≤35 kg/m2
Key exclusion criteria (30 listed)
- History of chronic medical condition that would either interfere with the accurate assessment of the objectives of the study or increase the risk profile of the subject.
- Subjects with cardiovascular disease
- Subjects with diabetes
- Subjects with pulmonary diseases such as COPD or asthma
- History of severe allergic reactions of any type to medications, bee stings, food, or environmental factors or hypersensitivity or reaction to immunoglobins.
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 |
|---|---|---|
| ADM03820ADM03820 is a 1:1 mixture of two human IgG1 non-competitive binding anti-SARS-CoV-2 antibodies | Drug | Cohort 1: 150 mg IM injection of active drug or placebo, Cohort 2: 300 mg IM injection of active drug or placebo, Cohort 3: 300 mg IM injection of active drug or placebo, Cohort 4: 300 mg IM injection of active drug or placebo, Cohort 5: 600 mg IM injection of active drug or placebo |
| PlaceboPlacebo | Other | Cohort 1: 150 mg IM injection of active drug or placebo, Cohort 2: 300 mg IM injection of active drug or placebo, Cohort 3: 300 mg IM injection of active drug or placebo, Cohort 4: 300 mg IM injection of active drug or placebo, Cohort 5: 600 mg IM injection of active drug or placebo |
Primary outcome
The Number of Participants With Serious Adverse Events Following Administration of ADM03820 to the Final Visit
Time frame: 540 days for Cohorts 1-4, 365 days for Cohort 5, and up to 540 days for placebo
Determine number of SAEs after dosing through the final visit
The Number of Participants With AEs Following Administration of ADM03820 to the Final Visit
Time frame: 540 days for Cohorts 1-4, 365 days for Cohort 5, and up to 540 days for placebo
Determine the number of AEs after dosing
The Number of Participants With Changes From Baseline in Physical Examination, Vital Signs, and Clinical Safety Laboratory Values Following Administration of ADM03820 to the Final Visit
Time frame: 540 days
The number of participants that were includes in this data are those who had clinically significant physical examinations, vital signs, and clinical safety laboratory values following administration of ADM03820 to the final visit.
11 secondary outcomes
The Assessment of Peak Plasma Concentration (Cmax) for Total Antibodies of ADM03820 as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Methods Designed for Total Monoclonal Antibody in the Drug Product (Cohorts 1-2).
Time frame: pre-dose, 2, 4, 8, and 24 hours post-dose, and on Days 3, 4, 8, 15, 30, 45, 60, 90, 120, 150, 180, and 365
The Assessment of Tmax for Total Antibodies of ADM03820 as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Methods Designed for Total Monoclonal Antibody in the Drug Product (Cohorts 1-2).
Time frame: pre-dose, 2, 4, 8, and 24 hours post-dose, and on Days 3, 4, 8, 15, 30, 45, 60, 90, 120, 150, 180, and 365
The Assessment of the Area Under the Plasma Concentration (AUC(0-t)) for the Total Antibodies of ADM03820 as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Methods Designed for Total Monoclonal Antibody in the Drug Product (Cohorts 1-2).
Time frame: pre-dose, 2, 4, 8, and 24 hours post-dose, and on Days 3, 4, 8, 15, 30, 45, 60, 90, 120, 150, 180, and 365
The Assessment of Peak Plasma Concentration (Cmax) for Each of the Monoclonal Antibodies of ADM03820 as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Methods Designed for Total Monoclonal Antibody in the Drug Product (Cohorts 3-5).
Time frame: pre-dose, 2, 4, 8, and 24 hours post-dose, and on Days 3, 4, 8, 15, 30, 45, 60, 90, 120, 150, 180, and 365
The Assessment of Tmax for Each of the Monoclonal Antibodies of ADM03820 as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Methods Designed for Total Monoclonal Antibody in the Drug Product (Cohorts 3-5).
Time frame: pre-dose, 2, 4, 8, and 24 hours post-dose, and on Days 3, 4, 8, 15, 30, 45, 60, 90, 120, 150, 180, and 365
The Assessment of Area Under the Plasma Concentration (AUC(0-t)) for Each of the Monoclonal Antibodies of ADM03820 as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Methods Designed for Total Monoclonal Antibody in the Drug Product (Cohorts 3-5).
Time frame: pre-dose, 2, 4, 8, and 24 hours post-dose, and on Days 3, 4, 8, 15, 30, 45, 60, 90, 120, 150, 180, and 365
Presence of Anti-drug Antibody (ADA) Levels
Time frame: pre-dose, and Day 15, 30, 45, 60, 90, 120, 150, and 180
The Number of Participants With SARS-CoV-2 RT-PCR Positive Symptomatic Illness Occurring After Dosing
Time frame: 365 days
The Number of Participants With SARS-CoV-2 RT-PCR Positive Severe or Critical Symptomatic Illness Occurring After Dosing
Time frame: 365 days
The Number of Participants With COVID-19 Related Emergency Department Visits Occurring After Dosing
Time frame: 365 days
The Presence of Neutralizing Antibody Concentrations of ADM03820 as Measured by Microneutralization (MN) Methods
Time frame: 180 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34473343Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADM03820 in people with SARS-CoV-2, run by Alachua Government Services, Inc. at 2 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 16 inclusion and 30 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: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Number of Participants With Serious Adverse Events Following Administration of ADM03820 to the Final Visit (time frame: 540 days for Cohorts 1-4, 365 days for Cohort 5, and up to 540 days for placebo). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04592549, which also lists 1 linked publication.
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 7 Mar 2025.