COVID-19 Respiratory InfectionPhase 3NCT04986176
HC-1119 Adjuvant Treatment for Hospitalized COVID-19 Patients
A Phase 3 study testing HC-1119 in people with COVID-19 Respiratory Infection, run by Applied Biology, Inc..
Trial summary
The primary purpose of this study is to evaluate the efficacy of HC-1119 as an adjuvant treatment for hospitalized COVID-19 male and female patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- COVID-19 Respiratory Infection
- What is being tested?
- HC-1119
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 602 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2022to 31 Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to the hospital with symptoms of COVID-19.
- Male and females age ≥18 years old.
- Confirmed positive SARS-CoV-2, through existing RT-PCR test within 7 days prior to randomization.
- Patients with clinical status categorized of scores 4, 5, or 6 on the COVID-19 Ordinal Scale:
- 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID - 19 related or otherwise);
- 5) Hospitalized, requiring supplemental oxygen;
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- 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices;
- Participant able to swallow 4 capsules sequentially of the medication under investigation/ placebo
- Coagulation: INR ≤ 1.5 ×ULN, and APTT ≤ 1.5×ULN
- Women of child-bearing potential must have negative results of plasma pregnancy test (serum HCG).
- Participant (or legally authorized representative) gives written informed consent prior to performing any study procedures.
- Participant (or legally authorized representative) agree that participant will not participate in another COVID-19 trial while participating in this study.
Who cannot join
- Participant enrolled in another interventionist study for COVID -19 treatment.
- Patients requiring mechanical ventilation.
- Patients taking an anti-androgen of any type including: androgen depravation therapy, 5-alpha reductase inhibitors, etc, having last dose of treatment less than 3 months prior to screening.
- Patients who are allergic to the investigational product or similar drugs (or any excipients).
- Patients has malignant tumors in the past 5 years, except for completed resected basal cell and squamous cell skin cancer and completely resected carcinoma in situ of any type.
- Patient with known serious cardiovascular disease:
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- Heart Failure NYHA III.
- Heart Failure NYHA IV.
- Angina class III -Canadian cardiovascular Society.
- Angina class IV -Canadian cardiovascular Society
- Angina with recent onset of symptoms, whose symptoms started 30 days or less.
- Myocardial infarction the last 3 months.
- Stroke in the last 3 months.
- Patient with a history of seizures/epilepsy.
- Patient taking any medications (or combination of medications) that could induce seizures/epilepsy during the study period.
- Patient with uncontrolled medical conditions despite adequate medication, that could compromise participation in the study (e.g., uncontrolled hypertension, hypothyroidism, diabetes mellitus).
- Known diagnosis of human immunodeficiency virus (HIV), hepatitis C, active hepatitis B, treponema pallidum (testing is not mandatory).
- Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 5 times the upper limit of normal.
- Estimated glomerular filtration rate (eGFR) < 30 ml/min.
- Severe kidney disease requiring dialysis.
- Patient likely to transfer to another hospital within 28 days after hospitalization.
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless using a highly effective method of contraception (detailed in the study protocol) throughout the study and for 3 months after stopping treatment with HC-1119.
- Sexually active men who refuse to use a condom during intercourse while taking HC-1119 and for 3 months after stopping treatment.
- Pregnant, breastfeeding, or women planning to become pregnant 3 months after treatment with HC-1119
- Participant (or legally authorized representative) not willing or unable to provide informed consent
About this study
The primary purpose of this study is to evaluate the efficacy of HC-1119 as an adjuvant treatment for hospitalized COVID-19 male and female patients.
Read the detailed description
This study is designed as a prospective, superiority, interventionist, placebo-controlled, double-blinded, randomized parallel assignment study. The study evaluates the efficacy and safety of HC- 1119.
Participants will be screened for eligibility; the assessment should be completed prior to any randomization to avoid screening failures to a maximum extent. Eligible participants (men and women) will be randomized 1:1 between arms (HC-1119 and placebo). HC-1119 and placebo will be administered orally.
The dosing regimen is 160 mg daily for 14 consecutive days. All patients will receive in parallel the standard treatment for COVID -19, according to the institution's protocol.
An electronic program will be used to manage randomization and drug shipment. The whole process will be handled in a manner that is blinded for the treatment received to all involved study personnel. The study follow up period will be 28 days after the first treatment.
- Conditions
- COVID-19 Respiratory Infection
- Being tested
- HC-1119, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HC-1119Drug
oral
PlaceboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| HC-1119 + Usual Care | Experimental | 4 (40mg) soft gel capsule, 160 mg total Receives: Drug: HC-1119 |
| Placebo + Usual Care | Placebo comparator | 4 soft gel capsule Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality risk ratio assessed by the proportion of patient deaths in both study arms.
The proportion of patients reaching score 8 (death) on the COVID-19 ordinal scale at any given time up to 28 days for both study arms.
Measured: 28 days
Secondary outcomes (10)
Recovery ratio assessed by measuring the proportion of recovered patients in both study arms.
Recovery will be defined as reaching scores 1 (Not hospitalized, no limitations on activities) and 2 (Not hospitalized, limitation on activities and/or requiring home oxygen) on the COVID-19 ordinal scale.
Measured: 28 days
Recovery ratio assessed by measuring the proportion of recovered patients in both study arms.
Recovery will be defined as reaching scores 1 (Not hospitalized, no limitations on activities) and 2 (Not hospitalized, limitation on activities and/or requiring home oxygen) on the COVID-19 ordinal scale.
Measured: 14 days
Post-randomization time to recover/alive hospital discharge assessed by the median days (interquartile range) of time to recover.
The median days (interquartile range) of time to recover will be calculated based on the number of days subjects will lead to reach scores 1 and 2 in the COVID-19 ordinal scale.
Measured: 28 days
Hazard ratio for death assessed by measuring the proportion of deaths by time in both study arms.
The percentage of patients that reached score 8 (death) in the COVID-19 ordinal scale at any given time up to 28 days for both study arms will allow for the calculation of the hazard ratio for death.
Measured: 28 days
Pharmacokinetics of HC-1119 assessed by area under the plasma concentration-time curve from time 0 to infinity (∞) (AUC0-∞)
Measured: 14 days
Pharmacokinetics of HC-1119 assessed by area under the plasma concentration-time curve from time 0 to time t of the last measurable concentration (AUC 0-t)
Measured: 14 days
Pharmacokinetics of HC-1119 assessed by peak concentration (Cmax)
Measured: 14 days
Pharmacokinetics of HC-1119 assessed by peak time (Tmax)
Measured: 14 days
Pharmacokinetics of HC-1119 assessed by elimination half-life (t 1/2)
Measured: 14 days
Efficacy of concomitant therapies assessed by sensitivity analysis of the primary, and key secondary outcomes.
Sensitivity analysis of the primary, and key secondary outcomes to evaluate the efficacy of concomitant therapy including off-label use of marketed medications that are intended as treatment for COVID 19 and are given to patient prior to and during the study.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start15 Apr 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Respiratory InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, superiority, interventional, placebo-controlled, double-blinded, randomized, parallel-assignment study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 602 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Applied Biology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hinova Pharmaceuticals Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986176
- Sponsor's protocol ID
- HC-1119-DRUG-SARS-001
- Status last verified
- Jul 2021
- First submitted
- 28 Jul 2021
- Last updated
- 18 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HC-1119 Adjuvant Treatment for Hospitalized COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04986176
- Acronym / sponsor ID
- HC-1119-DRUG-SARS-001
- Conditions
- COVID-19 Respiratory Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 602 participants (estimated)
- Lead sponsor
- Applied Biology, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Hinova Pharmaceuticals Inc.
- Study start
- 15 Apr 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to evaluate the efficacy of HC-1119 as an adjuvant treatment for hospitalized COVID-19 male and female patients.
Detailed description
This study is designed as a prospective, superiority, interventionist, placebo-controlled, double-blinded, randomized parallel assignment study. The study evaluates the efficacy and safety of HC- 1119.
Participants will be screened for eligibility; the assessment should be completed prior to any randomization to avoid screening failures to a maximum extent. Eligible participants (men and women) will be randomized 1:1 between arms (HC-1119 and placebo). HC-1119 and placebo will be administered orally.
The dosing regimen is 160 mg daily for 14 consecutive days. All patients will receive in parallel the standard treatment for COVID -19, according to the institution's protocol.
An electronic program will be used to manage randomization and drug shipment. The whole process will be handled in a manner that is blinded for the treatment received to all involved study personnel. The study follow up period will be 28 days after the first treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Prospective, superiority, interventional, placebo-controlled, double-blinded, randomized, parallel-assignment study
| Arm | Type | Receives |
|---|---|---|
| HC-1119 + Usual Care | Experimental | Drug: HC-11194 (40mg) soft gel capsule, 160 mg total |
| Placebo + Usual Care | Placebo comparator | Drug: Placebo4 soft gel capsule |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Admitted to the hospital with symptoms of COVID-19.
- Male and females age ≥18 years old.
- Confirmed positive SARS-CoV-2, through existing RT-PCR test within 7 days prior to randomization.
- Patients with clinical status categorized of scores 4, 5, or 6 on the COVID-19 Ordinal Scale:
- Participant able to swallow 4 capsules sequentially of the medication under investigation/ placebo
Key exclusion criteria (25 listed)
- Participant enrolled in another interventionist study for COVID -19 treatment.
- Patients requiring mechanical ventilation.
- Patients taking an anti-androgen of any type including: androgen depravation therapy, 5-alpha reductase inhibitors, etc, having last dose of treatment less than 3 months prior to screening.
- Patients who are allergic to the investigational product or similar drugs (or any excipients).
- Patients has malignant tumors in the past 5 years, except for completed resected basal cell and squamous cell skin cancer and completely resected carcinoma in situ of any type.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HC-1119oral | Drug | HC-1119 + Usual Care |
| Placebooral | Drug | Placebo + Usual Care |
Primary outcome
All-cause mortality risk ratio assessed by the proportion of patient deaths in both study arms.
Time frame: 28 days
The proportion of patients reaching score 8 (death) on the COVID-19 ordinal scale at any given time up to 28 days for both study arms.
10 secondary outcomes
Recovery ratio assessed by measuring the proportion of recovered patients in both study arms.
Time frame: 28 days
Recovery ratio assessed by measuring the proportion of recovered patients in both study arms.
Time frame: 14 days
Post-randomization time to recover/alive hospital discharge assessed by the median days (interquartile range) of time to recover.
Time frame: 28 days
Hazard ratio for death assessed by measuring the proportion of deaths by time in both study arms.
Time frame: 28 days
Pharmacokinetics of HC-1119 assessed by area under the plasma concentration-time curve from time 0 to infinity (∞) (AUC0-∞)
Time frame: 14 days
Pharmacokinetics of HC-1119 assessed by area under the plasma concentration-time curve from time 0 to time t of the last measurable concentration (AUC 0-t)
Time frame: 14 days
Pharmacokinetics of HC-1119 assessed by peak concentration (Cmax)
Time frame: 14 days
Pharmacokinetics of HC-1119 assessed by peak time (Tmax)
Time frame: 14 days
Pharmacokinetics of HC-1119 assessed by elimination half-life (t 1/2)
Time frame: 14 days
Efficacy of concomitant therapies assessed by sensitivity analysis of the primary, and key secondary outcomes.
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HC-1119 in people with COVID-19 Respiratory Infection, run by Applied Biology, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality risk ratio assessed by the proportion of patient deaths in both study arms. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022.