Mild to Moderate COVID-19Phase 3COMBAATNCT04705844
Study of Adalimumab or Placebo in Patients With Mild to Moderate COVID-19 (COMBAAT)
A Phase 3 study testing Adalimumab in people with Mild to Moderate COVID-19, run by Alachua Government Services, Inc..
Trial summary
Clinical study of Humira (adalimumab) or placebo in subjects with mild-moderate COVID-19 Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Mild to Moderate COVID-19
- What is being tested?
- Adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Sep 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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
Who cannot join
- 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.
Show all 24Show fewer
- 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.
About this study
Official title: Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Adalimumab (Humira) or Placebo in Patients With Mild-Moderate COVID-19
Clinical study of Humira (adalimumab) or placebo in subjects with mild-moderate COVID-19
- Conditions
- Mild to Moderate COVID-19
- Being tested
- Adalimumab, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
Also called Humira
adalimumab (160 mg administered as 4×40 mg subcutaneous [SC] injections at separate sites on the thigh or abdomen)
PlaceboDrug
placebo (4 SC injections of equal volume administered at separate sites on the thigh or abdomen)
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab | Experimental | single dose of adalimumab(160 mg administered as 4×40 mg subcutaneous [SC] injections at separate sites on the thigh or abdomen Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 28 Days
Secondary outcomes (1)
Assess the impact of treatment with adalimumab on clinical course of COVID-19 infection
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
Measured: 120 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study startSep 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Why it stopped: study withdrawn prior to screening subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate COVID-19Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alachua Government Services, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharm-Olam, LLC, Chemical, Biological, Radiological, and Nuclear Medical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705844
- Sponsor's protocol ID
- A21-070
- Acronym
- COMBAAT
- Status last verified
- Mar 2022
- First submitted
- 10 Jan 2021
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Adalimumab (Humira) or Placebo in Patients With Mild-Moderate COVID-19
- ClinicalTrials.gov ID
- NCT04705844
- Acronym / sponsor ID
- COMBAAT / A21-070
- Conditions
- Mild to Moderate COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study withdrawn prior to screening subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alachua Government Services, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Pharm-Olam, LLC, Chemical, Biological, Radiological, and Nuclear Medical
- Study start
- Sep 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical study of Humira (adalimumab) or placebo in subjects with mild-moderate COVID-19
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Adalimumab | Experimental | Drug: Adalimumabsingle dose of adalimumab(160 mg administered as 4×40 mg subcutaneous [SC] injections at separate sites on the thigh or abdomen |
| Placebo | Placebo comparator | Drug: Placebosingle dose of placebo (administered as 4×40 mg subcutaneous [SC] injections at separate sites on the thigh or abdomen |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
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 |
|---|---|---|
| AdalimumabAlso: Humiraadalimumab (160 mg administered as 4×40 mg subcutaneous [SC] injections at separate sites on the thigh or abdomen) | Drug | Adalimumab |
| Placeboplacebo (4 SC injections of equal volume administered at separate sites on the thigh or abdomen) | Drug | Placebo |
Primary outcome
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
1 secondary outcome
Assess the impact of treatment with adalimumab on clinical course of COVID-19 infection
Time frame: 120 Days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Mild to Moderate COVID-19
Not yet recruitingPhase 1/2
Evaluation of the Safety and Efficacy of XoGlo Pro, a Placental Mesenchymal Stem Cell-derived Extracellular Vesicles in Treating COVID-19 Symptoms
COVID-19
RecruitingPhase 1/2
SARS-CoV-2 CTLS for Mild to Moderate COVID-19 Disease
Covid19
Recruiting
Local Thermotherapy for Patients With Mild-to-moderate COVID-19
COVID-19, Thermotherapy
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adalimumab in people with Mild to Moderate COVID-19, run by Alachua Government Services, Inc..
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 11 inclusion and 24 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: withdrawn, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2022.