Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-25 @ 4:42 AM
NCT ID:
NCT04414618
Eligibility Criteria:
Inclusion Criteria:
1. Adult male or female ≥18 to ≤80 years of age
2. Proven COVID-19 infection per RT-PCR assay of a pharyngeal sample (nasopharyngeal or oropharyngeal) AND pneumonia defined as radiographic opacities on chest X-ray
3. The patient requires supplemental oxygen at baseline
4. The patient, guardian or legal representative has signed a written IRB-approved informed consent.
5\) Male participants with female partners of child-bearing potential agree to one of the following methods of contraception during the treatment period and for at least 1 month after the last dose of study drug:
* Abstinence from penile-vaginal intercourse and agree to remain abstinent.
* Male condom, with female partner using a highly effective contraceptive method. (For further details regarding highly effective contraceptive methods please see section 9.3.)
In addition, male participants must refrain from donating sperm for the duration of the study and for 1 months after last dose of study drug.
Male participants with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile penetration for at least 1 months after the last dose of study drug
Female participants:
A female participant is eligible to participate if she is:
1. not pregnant
2. not breastfeeding
3. not a woman of child-bearing potential (WOCBP, as defined in Section 9.3)
4. a WOCBP who agrees to use a highly effective method of contraception consistently and correctly during the treatment period and for at least 1 months after the last dose of study drug (please see further details on Section 9.3).
Exclusion Criteria:
1. Any co-morbidity that may add risk to the treatment in the judgement of the investigator.
2. Requiring intubation and mechanical ventilation
3. Patient having a do not intubate or do not resuscitate order
4. Oxygen saturation \>95% on room air
5. Any preexisting respiratory condition that requires intermittent or continuous ambulatory oxygen prior to hospitalization
6. Patient is, in the investigator's clinical judgment, unlikely to survive \>72 hours
7. Pregnant or nursing women
8. Unwillingness or inability to comply with procedures required in this protocol.
9. Corrected QT (QTc) interval on electrocardiogram (ECG) \>470 ms for females or \>450 ms for males, calculated using Friedericia's formula (QTcF)
10. AST (SGOT) or ALT (SGPT) \> 2.5 x upper limit of normal (ULN)
11. Bilirubin \>2.0 x ULN (except where bilirubin increase is due to Gilbert's Syndrome)
12. Serum creatinine \>2.0 X ULN
13. Absolute neutrophil count \<1000 cells/mm3
14. Platelet count \<75,000/mm3
15. Hemoglobin \<8.0 g/dL
16. Currently taking medications that are sensitive CYP3A4, CYP1A2, CYP2C9, or CYP2C19 or CYP2D6 substrates and have a narrow therapeutic index. These should be decided in discussion with the Medical Monitor on a case-by-case basis.
17. Currently taking medications that are strong inducers or inhibitors of CYP2D6 and CYP3A4. These should be decided in discussion with the Medical Monitor on a case-by-case basis.
18. Currently taking warfarin, apixaban, argatroban or rivaroxaban.
19. Current drug or alcohol abuse.
20. Currently participating in a clinical study assessing pharmacological treatments, including anti-viral studies.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04414618
Study Brief:
Protocol Section:
NCT04414618