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Monoclonal Antibodies

Monoclonal Antibody Cocktail for COVID-19

Phase 1
Waitlist Available
Research Sponsored by Ology Bioservices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 540 days
Awards & highlights

Study Summary

This trial is testing a new drug to see if it's safe and effective in preventing COVID-19.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~540 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 540 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The number of participants with AEs following administration of ADM03820 to the final visit
The number of participants with Serious Adverse Events following administration of ADM03820 to the final visit
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
Secondary outcome measures
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).
The assessment of Area under the plasma concentration (AUC(0-t)) for neutralizing antibody concentrations of ADM03820 as measured by microneutralization (MN) methods
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).
+10 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Cohort 5: 600 mg IM injection of active drug or placeboExperimental Treatment2 Interventions
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
Group II: Cohort 4: 300 mg IM injection of active drug or placeboExperimental Treatment2 Interventions
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
Group III: Cohort 3: 300 mg IM injection of active drug or placeboExperimental Treatment2 Interventions
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
Group IV: Cohort 2: 300 mg IM injection of active drug or placeboExperimental Treatment2 Interventions
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.
Group V: Cohort 1: 150 mg IM injection of active drug or placeboExperimental Treatment2 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ADM03820
2020
Completed Phase 1
~50

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Ology BioservicesLead Sponsor
36 Previous Clinical Trials
32,238 Total Patients Enrolled
2 Trials studying COVID-19
Enabling Biotechnologies (EB)UNKNOWN
1 Previous Clinical Trials
1 Trials studying COVID-19

Media Library

ADM03820 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04592549 — Phase 1
COVID-19 Research Study Groups: Cohort 5: 600 mg IM injection of active drug or placebo, Cohort 4: 300 mg IM injection of active drug or placebo, 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
COVID-19 Clinical Trial 2023: ADM03820 Highlights & Side Effects. Trial Name: NCT04592549 — Phase 1
ADM03820 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04592549 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings for individuals to join this experiment?

"This medical study, which was initially posted on December 4th 2020 according to clinicaltrials.gov, is actively recruiting participants with recent updates being made as of August 3rd 2022."

Answered by AI

Is the minimum age requirement for candidates in this experiment under 18?

"Patients aged between 18 and 55 are eligible for this research."

Answered by AI

Do I meet the criteria to partake in this research?

"This clinical trial is recruiting 50 people between the ages 18 and 55 who have contracted coronavirus disease 2019 (COVID-19). All participants must meet the following criteria: comprehension of informed consent, Body Mass Index (BMI) ranging from 18.5 to 35 kg/m2, a woman not pregnant or lactating nor postmenopausal for at least one year without menses with an appropriately elevated follicle stimulating hormone level or surgically sterilized via bilateral oophorectomy or hysterectomy, males and females that commit to using contraception throughout the duration of study, screening laboratory tests within normal ranges deemed clinically"

Answered by AI

How many participants have expressed interest in this medical experiment?

"Affirmative. Data located on clinicaltrials.gov verifies that this medical study, initially posted on December 4th 2020, is actively looking for participants. 50 candidates will be allowed to enroll between 2 different sites."

Answered by AI

Is the administration of ADM03820 likely to cause any adverse effects?

"ADM03820's safety was rated a 1 according to the evaluation conducted by Power, as this is an early-phase trial that has limited data indicating its efficacy or hazard levels."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Monoclonal Antibody Cocktail Being Tested for the Prevention of COVID-19
2020. "Study of Monoclonal Antibody Cocktail Being Tested for the Prevention of COVID-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04592549.
~11 spots leftby May 2025
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