A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER PHASE IIA STUDY OF XXX + STANDARD OF CARE (SOC) VS SOC IN THE TREATMENT OF HOSPITALIZED PATIENTS WITH COVID-19

About this Study

To measure the effect of XXX + standard of care (SoC) vs placebo +
SoC on Day 28, on disease progression in the confirmed coronavirus
disease 2019 (COVID-19) patient population. Disease progression is
defined as the proportion of patients who are not alive or have
respiratory failure (defined as the need for invasive or non-invasive
mechanical ventilation, high-flow oxygen, or extracorporeal membrane
oxygenation [ECMO])

Sponsor Protocol ID:pending
IRB Number:pending
Pending Activation
Interventional
Phase 2
October 22, 2020
Eligibility Criteria
Both Male and Female
No
No
No

Inclusion Criteria
Individuals must meet all of the following criteria to be included in the study:
1. The patient must be willing and able to give informed consent to
participate in the study and to adhere to the procedures stated in the
protocol or, for adults incapable of consenting due to their medical
condition (eg, too weak or debilitated, severe shortness of breath) or due to literacy issues, the patient’s legally authorized representative (LAR) must be willing and able to give informed consent on behalf of the patient to participate in the study as permitted by local regulatory
authorities, IRBs/IECs, or local laws.
2. The patient is male or female adult ≥18 years (as per local laws) of age at the time of giving informed consent.
3. The patient is admitted to a hospital and has a positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test. Note: If the patient has had previous confirmation of SARS-CoV-2 (within 7 days of Day 1), the SARS-CoV-2 test at screening is not required.
4. The patient has the presence of any symptom(s) suggestive of moderate or severe systemic illness with COVID-19 on Day 1 such as presence of fever (≥38.0°C [≥100.4°F] by any route), “feeling hot,” “feeling sweaty,” headache, malaise, fatigue, muscle pain, diarrhea, nausea, vomiting,
cough, sore throat, or shortness of breath upon exertion and/or at rest, or respiratory distress.

Exclusion Criteria
1. The patient has a documented current liver disease, or known hepatic or biliary abnormalities (with the exception of asymptomatic gallstones) at screening or on Day 1.
2. The patient has a Child Pugh score ≥ C.
3. The patient has a documented medical history of infection with human immunodeficiency virus or hepatitis A, B, or C at screening or on Day 1
4. The patient has a documented active infection with tuberculosis at
screening or on Day 1.
5. The patient has clinically significant ECG abnormalities at screening or on Day 1.
6. The patient requires dialysis or is on any renal replacement therapies at
screening or on Day 1.
7. A female patient who is pregnant or planning to become pregnant during the study, breastfeeding, or has a positive pregnancy test at screening (by serum) and prior to dosing on Day 1 (by urine) as determined by human
chorionic gonadotrophin tests.
8. The patient is planning to donate or bank ova or sperm from Day 1 until 30 days after the last dose of study drug.
9. The patient has a known history of drug abuse within 6 months of study start that would interfere with the patient’s participation in the study.
10. The patient has a history of sensitivity to any of the study medications,or components thereof or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, would contraindicate their participation.
16. The patient will be transferred to another hospital which is not a study site within 72 hours. Note: if the investigator has admitting privileges to the transfer hospital, the patient may be considered for randomization.
17. The patient cannot read and speak either English or Spanish. Note: If according to the hospital’s procedures the patient’s LAR or caregiver can interpret for a patient who cannot read or speak English, then a patient who cannot read and speak either English or Spanish would not be
excluded.
18. The investigator makes a decision that study involvement is not in
patient’s best interest, or the patient has any condition, in the opinion of the investigator, that will not allow the protocol to be followed safely.

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COVID-19 (Coronavirus)
Participating Locations
University Hospital
Contact Information
Contact Name: Amy Wigglesworth
Phone Number: 601-815-3464
Email: ajwigglesworth@umc.edu
Principal Investigator:Marshall, Gailen D, M.D.Ph.D., M.D., Ph.D.
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