Status and phase
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About
This is a randomized, single-center, single-blind, placebo controlled, study to evaluate efficacy of PanCytoVir™ 500 mg twice daily and 1000 mg twice daily for the treatment of non-hospitalized patients with COVID-19 infection.
Enrollment
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Inclusion criteria
Exclusion criteria
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).
Patients with known blood dyscrasia and uric acid kidney stones.
Females who are pregnant, breast feeding, or planning a pregnancy.
Females of childbearing potential who do not agree to utilize an adequate effective form of contraception.
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.
History of alcohol, chemical, or drug abuse or dependence as per DSM IV criteria within past 6 months.
Current active malignancy or history of malignancy within the past five years.
Known hypersensitivity history to Investigational Products or any of its component.
Any patient on the following medications: Erdafitinib- Lasmiditan- Quinidine due to potential severe drug interaction.
Patients with the following conditions:
Has a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, hepatocellular carcinoma.
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.
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.
Is taking or is anticipated to require any prohibited medications or therapies.
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.
Any patient that is already taking Investigational Medicinal Products. -
Primary purpose
Allocation
Interventional model
Masking
75 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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