| Eligibility |
Inclusion Criteria:
1. Non-hospitalized Patients with RT-PCR confirmed COVID-19 in = 48 hours prior to
randomization.
2. Patients with WHO Ordinal Scale score 1 and 2.
3. Patient has presented within 5 days or less of randomization with at least one early
onset COVID-19 symptom (i.e. fever or chills, cough, shortness of breath or difficulty
breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore
throat, congestion or runny nose, nausea, vomiting or diarrhea).
4. Men and non-pregnant women, 18 - 65 years of age.
5. Patient has estimated glomerular filtration rate (eGFR) =30 mL/min using the
Cockcroft-Gault formula.
6. Willing to participate in this study, signed Informed Consent and willing to
participate in regular follow-up during the study.
7. Able to understand and cooperate with study procedures. -
Exclusion Criteria:
1. Subjects hospitalized (a) Patients with severe or critical forms of COVID-19 illness
or those who are on ventilator support, ECMO, or shock requiring vasopressor support
or those with cytokine storm; even not in hospital (b) Patients hospitalized for
treatment of severe illnesses (c) "Long COVID-19" syndrome (defined as a diverse set
of symptoms that persist after a minimum of 4 weeks from the onset of a diagnosed
COVID-19 infection. Common symptoms include respiratory system disorders, nervous
system and neurocognitive disorders, mental health disorders, metabolic disorders,
cardiovascular disorders, gastrointestinal disorders, malaise, fatigue,
musculoskeletal pain, and anemia).
2. Patients with known blood dyscrasia and uric acid kidney stones.
3. Females who are pregnant, breast feeding, or planning a pregnancy.
4. Females of childbearing potential who do not agree to utilize an adequate effective
form of contraception.
5. Males with partners of child-bearing potential unwilling to take measures not to
father children by using a barrier method of contraception (condom plus spermicide) or
to sexual abstinence effective from the first administration of any of the IPs
throughout the trial.
1. Men with partners of child-bearing potential unwilling to ensure that their
partner uses an effective method of contraception for the same duration for
example, hormonal contraception, intrauterine device, diaphragm with spermicidal
gel, or sexual abstinence. Men with pregnant or lactating partners unwilling to
use barrier method contraception (for example, condom plus spermicidal gel) to
prevent exposure of the fetus or neonate.
2. Abstinence is only considered to be an acceptable method of contraception when
this is in line with the preferred and usual lifestyle of the patients. Periodic
abstinence (e.g., calendar, ovulation, sympathothermal, postovulation methods)
and withdrawal are not acceptable methods of contraception.
6. History of alcohol, chemical, or drug abuse or dependence as per DSM IV criteria
within past 6 months.
7. Current active malignancy or history of malignancy within the past five years.
8. Known hypersensitivity history to Investigational Products or any of its component.
9. Any patient on the following medications: Erdafitinib- Lasmiditan- Quinidine due to
potential severe drug interaction.
10. Patients with the following conditions:
1. Immunosuppression
2. HIV
3. Current neoplasms
11. Has a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis,
end-stage liver disease, hepatocellular carcinoma.
12. Any other clinically significant abnormal medical condition, which in the
Investigator's judgment, would put the patient at increased risk of illness or injury
would interfere with study participation or would interfere with the evaluation or
quality of the data.
13. Investigator's judgment that participation would not be in the best interest of the
participant or that could prevent, limit, or confound the protocol-specified
assessments including but not limited to: participants who are not expected to survive
longer than 48 hours after randomization, or participants with a recent history of
mechanical ventilation, or participants with conditions that could limit
gastrointestinal absorption of capsule contents.
14. Is taking or is anticipated to require any prohibited medications or therapies.
15. Participation in another trial within previous 3 months and is unwilling to abstain
from participating in another interventional clinical study through Day 28 with an
investigational compound or device, including those for COVID-19 therapeutics.
16. Any patient that is already taking Investigational Medicinal Products. -
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