Study to Evaluate the Safety and Efficacy of a Monoclonal Antibody Cocktail for the Prevention of COVID-19

NCT05142527 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: ADM03820-002
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Phase 2/3, randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety, tolerability, and efficacy of ADM03820 to prevent symptomatic COVID-19 in adult subjects (≥ 18 years of age).

Conditions

COVID-19

Outcome Measures

Primary Outcomes (4)

• Incidence and severity of reactogenicity through Day 7 and adverse events (AEs) through end of study (Phase 2)

  Number of participants with AEs and reactogenicity symptoms. FDA Toxicity Grading Scale for Local and General Systemic Reactogenicity will assess severity.

  540 days

• Incidence of SAEs and medically-attended AEs (Phase 2)

  Number of participants with SAEs and medically-attended AEs through end of study

  540 days

• Occurrence of changes from baseline in physical examination, vital signs, and clinical safety laboratory values (Phase 2)

  Number of participants with changes from baseline

  365 days

• Incidence of symptomatic, virologically confirmed COVID-19 (Phase 3)

  Number of participants with symptomatic, virologically confirmed COVID-19

  Day 1 to Day 29

Secondary Outcomes (18)

• Incidence of symptomatic, virologically confirmed COVID-19 (Phase 2 and Phase 3)

  183 days

• Hospitalization (Phase 2 and Phase 3)

  183 days

• All-cause mortality (Phase 2 and Phase 3)

  183 days

• Incidence of AEs (Phase 2)

  540 days

• Incidence of SAEs (Phase 2)

  540 days

Other Outcomes (3)

• To assess Anti-SARS-CoV-2 Nucleoprotein (NP) antibody levels (Phase 2 and Phase 3)

  274 days

• Serum collection for future analysis (Phase 2 and Phase 3)

  365 days

• Collection of cDNA for SARS-CoV-2 sequence from subjects with positive RT-PCR assay (Phase 3)

  540 days

Study Arms (2)

High Dose IM injection of active drug or Placebo (Phase 2)

EXPERIMENTAL

Subjects will receive a high dose IM injection of either active drug or placebo. Approximately 300 subjects will receive active drug and approximately 150 subjects will receive placebo in the Phase 2 segment.

Drug: ADM03820; Other: Placebo

High Dose IM injection of active drug or Placebo (Phase 3)

EXPERIMENTAL

Subjects will receive a high dose IM injection of either active drug or placebo. Approximately 3000 subjects will receive active drug and approximately 1000 subjects will receive placebo in the Phase 3 segment

Drug: ADM03820; Other: Placebo

Interventions

ADM03820 DRUG

ADM03820 is a 1:1 mixture of two human IgG1 non-competitive binding anti-SARS-CoV-2 antibodies

High Dose IM injection of active drug or Placebo (Phase 2); High Dose IM injection of active drug or Placebo (Phase 3)

Placebo OTHER

Placebo

High Dose IM injection of active drug or Placebo (Phase 2); High Dose IM injection of active drug or Placebo (Phase 3)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent understood and signed prior to screening procedures
• Healthy male or non-pregnant, non-lactating female 18 years of age or older, inclusive on the day of dosing
• Subject willing to comply with and be available for all protocol procedures for the duration of the study

You may not qualify if:

• Subject with BMI ≥18.5 and ≤ 35 kg/m2
• Females of childbearing potential must have a negative urine pregnancy test on Day 1 prior to dosing 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 must agree to use medically effective contraception (methods with a failure rate of \< 1% per year when used consistently and correctly) from screening until last dose. Acceptable methods include: hormonal contraception including implants, injections or oral; two barrier methods, e.g., condom and cervical cap (with spermicide) or diaphragm (with spermicide); intrauterine device or intrauterine system; abstinence when this is the subject's preferred and usual lifestyle.
• Subject agrees to not donate bone marrow, blood, and blood products for at least 3 months after dosing
• Clinical laboratory results within normal ranges or are no greater than Grade 1 and deemed not clinically significant by medical monitor and PI. (Any subjects with results that are Grade 2 or above according to toxicity table (modified from FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial) will be excluded)
• Subject willing to provide verifiable identification and has means to be contacted and to contact the Principal Investigator (PI) during the study.
• 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
• History of diabetes (type 1 or type 2), cardiovascular disease, pulmonary disease, chronic obstructive pulmonary disease (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
• Known allergic reactions or history of anaphylaxis or any other serious adverse reactions to any of the study product components present in the formulation or in its processing, as listed in the Investigator Brochure
• Known to have HIV, HBsAg, or HCV per self-reported medical history
• Febrile illness with temperature ≥38°C within 7 days of dosing. (Subjects with acute febrile illness within 7 days of dosing may be rescreened no earlier than 7 days following resolution of symptoms).
• Rapid SARS CoV-2 antigen nasopharyngeal swab is positive on Day 1 prior to dosing or positive SARS-CoV-2 RT-PCR if result is received prior to dosing
• Female subject who is pregnant or breastfeeding
• Has previously received any coronavirus vaccine

Sponsors & Collaborators

• Alachua Government Services, Inc.: lead
• Enabling Biotechnologies (EB): collaborator

Related Publications (1)

• Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.

  PMID: 35713300 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

ADM03820

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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 2, 2021
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: April 1, 2024
• Last Updated: February 3, 2023

Record last verified: 2023-02