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