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Trial record 5 of 738 for:    ABP 501

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04705844
Recruitment Status : Withdrawn (study withdrawn prior to screening subjects)
First Posted : January 12, 2021
Last Update Posted : March 3, 2022
Sponsor:
Collaborators:
Pharm-Olam, LLC
Chemical, Biological, Radiological, and Nuclear Medical
Information provided by (Responsible Party):
Ology Bioservices

Tracking Information
First Submitted Date  ICMJE January 10, 2021
First Posted Date  ICMJE January 12, 2021
Last Update Posted Date March 3, 2022
Estimated Study Start Date  ICMJE September 2021
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2021)
  • 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 [ Time Frame: 28 Days ]
    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
  • Assess the safety of adalimumab in subjects with COVID-19 [ Time Frame: 28 Days ]
    Incidence of Grade 3 and Grade 4 clinical adverse events (AEs) from first dose through Day 28 following randomization
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2021)
Assess the impact of treatment with adalimumab on clinical course of COVID-19 infection [ Time Frame: 120 Days ]
Clinical status by 9-point WHO COVID 19 ordinal scale from first dose through Day 120 following randomization
  • Incidence of venous thromboembolism, CVA, myocardial infarction, and acute kidney injury C from first dose through Day 120 following randomization
  • Time to resolution of symptoms using 14 point COVID-19 Symptom Score from first dose through Day 120 following randomization
  • COVID-19 Clinical Assessment from first dose through Day 120 following randomization
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Adalimumab or Placebo in Patients With Mild to Moderate COVID-19 (COMBAAT)
Official Title  ICMJE Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Adalimumab (Humira) or Placebo in Patients With Mild-Moderate COVID-19
Brief Summary Clinical study of Humira (adalimumab) or placebo in subjects with mild-moderate COVID-19
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Randomized, Double-Blind, Placebo-Controlled
Primary Purpose: Treatment
Condition  ICMJE Mild to Moderate COVID-19
Intervention  ICMJE
  • Drug: Adalimumab
    adalimumab (160 mg administered as 4×40 mg subcutaneous [SC] injections at separate sites on the thigh or abdomen)
    Other Name: Humira
  • Drug: Placebo
    placebo (4 SC injections of equal volume administered at separate sites on the thigh or abdomen)
Study Arms  ICMJE
  • Experimental: Adalimumab
    single dose of adalimumab(160 mg administered as 4×40 mg subcutaneous [SC] injections at separate sites on the thigh or abdomen
    Intervention: Drug: Adalimumab
  • Placebo Comparator: Placebo
    single dose of placebo (administered as 4×40 mg subcutaneous [SC] injections at separate sites on the thigh or abdomen
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 22, 2021)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 10, 2021)
1444
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • Received GM-CSF agents (e.g., sargramostim) within 2 months prior to screening.
  • Treatment with other immunosuppressants in the 4 weeks prior to screening and in the judgment of the Investigator, the risk of immunosuppression with adalimumab is larger than the risk of COVID-19.
  • Treatment with small molecule tyrosine kinase inhibitors (e.g., baricitinib, ibrutinib, acalabrutinib, imatinib, gefitinib), in the 4 weeks prior to screening.
  • Received or contemplating receipt of any live vaccine or any investigational vaccine in the 4 weeks prior to screening.
  • Current participation or previous participation in any other clinical trial within 30 days prior to randomization.
  • Subjects with known hypersensitivity to adalimumab or excipients of adalimumab as stated in the label.
  • Pregnant female
  • Lactating female
  • Women of childbearing potential who do not 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04705844
Other Study ID Numbers  ICMJE A21-070
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Ology Bioservices
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Ology Bioservices
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Pharm-Olam, LLC
  • Chemical, Biological, Radiological, and Nuclear Medical
Investigators  ICMJE Not Provided
PRS Account Ology Bioservices
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP