Study of Adalimumab or Placebo in Patients With Mild to Moderate COVID-19 (COMBAAT)

NCT04705844 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: A21-070
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Clinical study of Humira (adalimumab) or placebo in subjects with mild-moderate COVID-19

Conditions

Mild to Moderate COVID-19

Outcome Measures

Primary Outcomes (2)

• Establish whether treatment with adalimumab is associated with a lower rate of progression to severe disease as defined by severe illness or critical illness, or death in outpatient subjects with COVID-19

  Proportion of subjects with the following outcomes attributed to COVID-19 from time of first dose through Day 28 following randomization: * Death * Alive and hospitalized or requiring supplemental oxygen for ≥1 hour * Alive and not hospitalized or requiring supplemental oxygen for ≥1 hour

  28 Days

• Assess the safety of adalimumab in subjects with COVID-19

  Incidence of Grade 3 and Grade 4 clinical adverse events (AEs) from first dose through Day 28 following randomization

  28 Days

Secondary Outcomes (1)

• Assess the impact of treatment with adalimumab on clinical course of COVID-19 infection

  120 Days

Study Arms (2)

Adalimumab

EXPERIMENTAL

single dose of adalimumab(160 mg administered as 4×40 mg subcutaneous \[SC\] injections at separate sites on the thigh or abdomen

Drug: Adalimumab

Placebo

PLACEBO COMPARATOR

single dose of placebo (administered as 4×40 mg subcutaneous \[SC\] injections at separate sites on the thigh or abdomen

Drug: Placebo

Interventions

Adalimumab DRUG

adalimumab (160 mg administered as 4×40 mg subcutaneous \[SC\] injections at separate sites on the thigh or abdomen)

Also known as: Humira

Adalimumab

Placebo DRUG

placebo (4 SC injections of equal volume administered at separate sites on the thigh or abdomen)

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject (or their legally authorized representative) is willing and able to provide written informed consent prior to performing study procedures.
• Understands and agrees to comply with planned study procedures.
• Male or non-pregnant female adult ≥60 and ≤ 80years of age OR male or non-pregnant female adult ≥40 and ≤80 years, with one or more of the following risk factors (asthma, diabetes, hypertension, obesity \[body mass index \>30\], cardiovascular disease).
• Has a laboratory-confirmed SARS-CoV-2 infection as determined by FDA-approved rapid diagnostic (e.g., polymerase chain reaction \[PCR\]) assay within the preceding 7 days (168 hours).
• Has at least 2 COVID-19 related symptoms on the 14-question COVID-19 questionnaire.
• Has peripheral capillary oxygen saturation (SpO2) \>93% by pulse oximetry.
• C-reactive protein (CRP) \>50 mg/L or lymphopenia (\<1.5×109/L) or neutrophilia (\>7.5×109/L).
• Agrees to the collection of blood and urine samples, nasal swabs , and non-invasive oxygen monitoring (via pulse oximeter) per protocol.
• Willing to receive 4 injections at separate sites on the thigh or abdomen.
• Women of childbearing potential must agree to either abstinence or use of at least one primary form of contraception (not including hormonal contraception) from the time of screening through Day 29 following randomization.
• Agrees to not participate in any other clinical trial (both pharmacologic and other types of interventions) through Day 29 following randomization

You may not qualify if:

• Received or contemplating any COVID-19 vaccine or participated in a COVID-19 vaccine trial.
• Subject is considered to be in their last few weeks of life prior to this acute illness.
• History of pulmonary alveolar proteinosis.
• History of hematopoietic stem cell transplant or solid organ transplant.
• Previous malignancy and lymphoproliferative disorders (within the last 5 years) with the exception of stable prostate cancer and basal cell carcinoma.
• Chronic obstructive pulmonary disease on long-term oxygen therapy - subjects with forced expiratory volume in 1 second known to be \<50% will also be excluded.
• Demyelinating disease.
• Known history of hepatitis B, HIV, or untreated hepatitis C infection
• Severe hepatic impairment or known cirrhosis - Child-Pugh score B or higher.
• Acute kidney injury Stage 3
• Tuberculosis or other severe infections such as (non-COVID-19) sepsis, abscesses, fungal superinfection and opportunistic infections requiring treatment.
• Positive Quantiferon Gold test at screening
• Moderate or severe heart failure (New York Heart Association Class III/IV).
• Treatment with monoclonal antibodies targeting cytokines (e.g., TNF inhibitors \[adalimumab, infliximab, etanercept, golimumab, certolizumab\]; anti-IL-1 \[e.g., anakinra, canakinumab\]; anti-IL-6 or anti-IL-6r \[e.g., tocilizumab, sarilumab, sitlukimab\]; or T-cells \[e.g., abatacept\]) in past 90 days (5 half-lives of the drug), or contemplating treatment with any of these agents during the trial period.
• Treatment with monoclonal antibodies targeting B-cells (e.g., rituximab, and including any targeting multiple cell lines including B-cells) in the 3 months prior to screening.

Sponsors & Collaborators

• Alachua Government Services, Inc.: lead
• Pharm-Olam, LLC: collaborator
• Chemical, Biological, Radiological, and Nuclear Medical: collaborator

MeSH Terms

Interventions

Adalimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomized, Double-Blind, Placebo-Controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized to receive a single dose of adalimumab or placebo. Subjects will receive standard care of therapy (per study site written policies or guidelines) together with adalimumab or matching placebo.

Study Record Dates

• First Submitted: January 10, 2021
• First Posted: January 12, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: March 3, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share