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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
Study Status:

Study Status

Actively Enrolling: The study is currently recruiting participants.

Closed for Enrollment: The study is not currently recruiting participants.

Pending Activation
Study Type:

Study Type

Interventional: A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study's protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.

Observational: A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific interventions/treatment. A patient registry is a type of observational study.

Interventional
Study Phase:

Study Phase

Early Phase 1 Trials (formerly listed as Phase 0): Exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body. They involve very limited human exposure to the drug and have no therapeutic or diagnostic goals (for example, screening studies, microdose studies).

Phase 1 Trials: Trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These trials usually involve a small number of participants.

Phase 2 Trials: Trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

Phase 3 Trials: Trials that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.

Phase 4 Trials: Trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that are required of or agreed to by the study sponsor. These trials gather additional information about a drug's safety, efficacy, or optimal use.

Phase 2
Online Start Date:

Online Start Date

The online start date is the day that this trial first appeared on the UMMC website, which is not necessarily the day that the trial first began at UMMC.

October 22, 2020
Eligibility Criteria
Biological Sex

Biological Sex Requirement

Indicates the sex of people who may participate in a clinical study (all, female, male). Sex is a person's classification as female or male based on biological distinctions. Sex is distinct from gender-based eligibility.

 Both Male and Female
Cancer Related?

Cancer Related

Some studies may be targeted to cancer-related treatments or research. Please read the study description and additional eligibility criteria for specific information.

No
Pediatric Related?

Pediatric Related

Some studies may be targeted to child-related treatments or research. Please read the study description and additional eligibility criteria for specific information.

No
Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Indicates whether people who do not have the condition/disease being studied can participate in the clinical study.

Healthy volunteers play an important role in research because they help define "normal" ranges. While they may receive no direct benefit, healthy volunteers choose to participate in clinical research because they want to help others and contribute to advancing science.

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 - UMMC
Contact Information
Contact Name: Amy Wigglesworth
Phone Number: 601-815-3464
Email: ajwigglesworth@umc.edu
Principal Investigator:Marshall, Gailen D, M.D., Ph.D.
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