Clinical trial NCT05442983: A Study to Evaluate the Efficacy of PanCytoVir™ for the Treatment of Non-Hospitalized Patients With COVID-19 Infection
Official title: A Randomized, Single-center, Single-blind, Placebo-controlled Study to Evaluate the Efficacy of PanCytoVir™ 500 mg Twice Daily and 1000 mg Twice Daily for the Treatment of Non-hospitalized Patients With COVID-19 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: TrippBio, Inc.
Sponsor class: INDUSTRY
First posted: 2022-07-05
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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. -

Primary outcomes:
measure: Time to Viral Clearance
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Pune
country: India
facility: PCMCs PGI Yashwantrao Chavan Memorial Hospital
Study officials:
affiliation: TrippBio, Inc.
name: David E Martin, PharmD
role: STUDY_DIRECTOR
References: