Corona Virus InfectionPhase 1PROPELNCT04632381
Intravenous Zotatifin in Adults With Mild or Moderate COVID-19
A Phase 1 study testing Zotatifin in people with Corona Virus Infection, run by Effector Therapeutics at 4 sites in United States.
Trial summary
To evaluate the safety and tolerability, the antiviral activity, and plasma pharmacokinetics (PK) of zotatifin administered intravenously (IV) to adults with mild or moderate COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Corona Virus Infection
- What is being tested?
- Zotatifin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jul 2021to 22 Sep 2023
- Phase
- Phase 1
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Has provided informed consent and any authorizations required by local law;
- Is a male or female patient ≥18 and <65 years of age;
- Has a laboratory-documented positive test for SARS CoV 2 infection as determined by local laboratory using a standard, Food and Drug Administration (FDA)-approved viral RNA or viral antigen assay from any oral or respiratory sample collected within 48 hours of randomization;
- Has at least 2 symptoms associated with COVID-19 (fever or chills, cough, shortness of breath or difficulty breathing on exertion, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea) starting no more than 5 days prior to randomization and has mild or moderate disease at screening and at time of randomization, defined as the following:
- Mild COVID-19
- Positive testing by standard reverse transcriptase polymerase chain reaction (RT-PCR) assay or equivalent test;
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- Symptoms of mild illness with COVID-19 that could include fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, without shortness of breath or dyspnea; and
- No clinical signs indicative of moderate, severe, or critical severity;
- Moderate COVID-19
- Positive testing by standard RT-PCR assay or equivalent testing;
- Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion;
- Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥20 breaths per minute, saturation of oxygen (SpO2) >93% on room air at sea level, heart rate ≥90 beats per minute; and
- No clinical signs indicative of severe or critical severity;
- Has adequate hepatic function during screening, defined as the following:
- Serum alanine aminotransferase ≤3 × upper limit of normal (ULN);
- Serum aspartate aminotransferase ≤3 × ULN; and
- Serum bilirubin (total) ≤1.5 × ULN (unless due to Gilbert's syndrome or hemolysis);
- Has adequate bone marrow function during screening, defined as the following:
- Absolute neutrophil count ≥1.0 × 10 9/L;
- Platelet count ≥75 × 109/L; and
- Hemoglobin ≥90 g/L (9.0 g/dL or 5.6 mmol/L);
- Has adequate renal function during screening, defined as measured or estimated glomerular filtration rate ≥60 mL/min, calculated by the Cockcroft-Gault formula using actual body weight;
- Female patients of childbearing potential must meet all of the following criteria:
- Is not pregnant (confirmed via a negative urine pregnancy test);
- Is not breastfeeding; and
- Is willing to use a protocol-recommended method of contraception or willing to abstain from heterosexual intercourse from the start of blinded study drug until at least 90 days after the last dose of blinded study drug; Note: A female patient is considered to be of childbearing potential unless she has had a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy; has medically documented ovarian failure (with serum estradiol and follicle-stimulating hormone levels within the institutional laboratory postmenopausal range and a negative serum or urine β-human chorionic gonadotropin); or is menopausal (age ≥55 years with amenorrhea for ≥6 months).
- Male patients who can father a child must meet all of the following criteria:
- Is willing to use a protocol-recommended method of contraception or willing to abstain from heterosexual intercourse with females of childbearing potential from the start of blinded study drug until at least 90 days after the last dose of blinded study drug; and
- Is willing to refrain from sperm donation from the start of blinded study drug until at least 90 days after the last dose of blinded study drug; Note: A male patient is considered able to father a child unless he has had a bilateral vasectomy with documented aspermia or a bilateral orchiectomy.
- Is willing to comply with the scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions; and Note: Psychological, social, familial, or geographical factors that may preclude adequate study participation should be considered.
- In the judgment of the Investigator, participation in the protocol offers an acceptable benefit to risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the patient's disease.
Who cannot join
- Is hospitalized for COVID-19;
- Has dyspnea at rest or while talking, or has signs and symptoms of overt or impending respiratory failure;
- Has significant cardiovascular disease, defined by myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism, within 3 months prior to randomization; symptomatic dysrhythmias or unstable dysrhythmias requiring medical therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association Class 3 or 4 congestive heart failure; ≥Grade 3 hypertension (diastolic blood pressure ≥100 mmHg or systolic blood pressure ≥160 mmHg); or history of congenital prolonged QT syndrome;
- Has a history of chronic obstructive pulmonary disease or bronchial asthma requiring continuous treatment and/or intermittent or continuous oxygen within the 90 days prior to screening; Note: Intermittent use of a β2-agonist inhaler is allowed.
- Has evidence of an ongoing or systemic bacterial, fungal, or viral infection (including upper respiratory tract infections) other than SARS-CoV-2 infection, recurrent or repeat SARS CoV 2 infection, or history of incompletely treated tuberculosis (TB) and/or suspected or known extrapulmonary TB; Note: Patients with localized fungal infections of the skin or nails are eligible. Patients may be receiving topical antifungals. Systemic administration of azole antifungals is prohibited (see Section 5.6).
- Has significant infiltrates (involving >50% of lung parenchyma) on an optional standard of care chest X-ray or other lung imaging exam within 1 week of screening;
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- Has known significant electrocardiogram abnormalities at screening, including unstable cardiac arrhythmia requiring medication, left bundle branch block, second-degree atrioventricular (AV) block type II, third-degree AV block, ≥Grade 2 bradycardia, or QTcF >450 msec for men or >470 msec for women;
- Has type 1 diabetes mellitus or type 2 diabetes mellitus;
- Has a body mass index (BMI) >30 kg/m2;
- Has received a live vaccine within 30 days prior to randomization;
- Has had major surgery within 4 weeks (inclusive) prior to randomization;
- Has had prior solid organ or bone marrow progenitor cell transplantation;
- Has a malignant tumor (excluding a malignant tumor cured with no recurrence in the past 2 years, completely resected basal cell and squamous cell carcinoma of the skin, and completely resected carcinoma in situ of any type);
- Has had prior high-dose chemotherapy requiring stem cell rescue;
- Has a history of or active uncontrolled systemic or local autoimmune disorders or other conditions that might impair or compromise the immune system;
- Has ongoing immunosuppressive therapy, including systemic corticosteroids; Note: At screening and during study participation, patients may be using systemic corticosteroids (doses ≤10 mg of prednisone or equivalent) or topical or inhaled corticosteroids.
- Has ongoing use of a therapeutic anticoagulant or history of bleeding disorder;
- Has ongoing use or plans to use antivirals against COVID-19;
- Has used a moderate or strong inhibitor or inducer of CYP3A4 within 7 days prior to randomization or is expected to require use of a moderate or strong CYP3A4 inhibitor or inducer during study participation;
- Has previously received investigational product in a clinical study within 30 days or within 5 elimination half-lives (whichever is shorter) prior to randomization or is planning to take part in another therapeutic clinical study while participating in this study; Note: Participation in observational studies is allowed.
- Has a known history of HIV or hepatitis B virus, or active hepatitis C virus infection;
- Has a known serious allergic reaction or hypersensitivity to components of zotatifin or placebo;
- Has a history of drug abuse or use of narcotics in the past 2 years that in the opinion of the Investigator will preclude study compliance; or
- Has any illness, medical condition, organ system dysfunction, or social situation, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to provide informed consent, adversely affect the patient's ability to cooperate and participate in the study, or compromise the interpretation of study results.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Pinnacle Research Group
Anniston, Alabama, 36207
National Institute of Allergy and Infectious Diseases
Bethesda, Maryland, 20814
Cullman Clinical Trials
Cullman, Alabama, 35055
Tampa General Hospital
Tampa, Florida, 33606
About this study
Official title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Trial of Intravenous Zotatifin in Adults With Mild or Moderate Coronavirus Disease 2019 (COVID-19)
To evaluate the safety and tolerability, the antiviral activity, and plasma pharmacokinetics (PK) of zotatifin administered intravenously (IV) to adults with mild or moderate COVID-19.
Read the detailed description
This randomized, double-blind, placebo-controlled, dose-escalating study will evaluate the safety and efficacy of zotatifin administered IV to adults with mild or moderate COVID 19.
Patients will be randomized to receive zotatifin or placebo in 3 cohorts of 12 patients each. Cohorts will be sequentially enrolled at progressively higher zotatifin dose levels. Study drug will not be administered to patients who are hospitalized. The second dose of study drug will not be administered should a patient progress from mild or moderate COVID-19 to severe COVID-19 prior to or on Day 8. Patients will assess and record their symptoms daily through Day 22 and at follow up (30 days after last infusion) (or at the early termination visit [if conducted]) in a paper patient diary using the WHO 9-point ordinal scale for clinical improvement. Other safety and efficacy measures will be assessed according to the Schedule of Procedures on Days 1, 4, 8, 10, 15 (end of treatment visit), and 22, and at follow up (30 days after last infusion). On non-dosing days, study visits will be conducted as home health visits, except for the follow-up visit, which will be conducted as a telephone visit.
- Conditions
- Corona Virus Infection
- Being tested
- Zotatifin, Placebo
- Keywords
- COVID-19
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZotatifinDrug
Also called Zota
Zotatifin is a potent and sequence-selective inhibitor of eukaryotic translation initiation factor (eIF) 4A1-mediated translation that imparts its regulation through a reversible enhancement of eIF4A1 binding to RNAs (ribonucleic acids) with specific polypurine motifs within the 5'-untranslated region (UTR).
PlaceboDrug
Also called PBO
5% dextrose injection, USP
| Study group | Role | What they receive |
|---|---|---|
| Active Arm, Zota Cohort 1 | Active comparator | 0.01 mg/kg zotatifin Receives: Drug: Zotatifin |
| Active Arm, Zota Cohort 2 | Active comparator | 0.02 mg/kg zotatifin Receives: Drug: Zotatifin |
| Active Arm, Zota Cohort 3 | Active comparator | 0.035 mg/kg zotatifin Receives: Drug: Zotatifin |
| Placebo | Placebo comparator | 5% dextrose injection, USP Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by the incidence of Treatment Emergent Adverse Events and Serious Adverse Events
Incidence of Treatment Emergent Adverse Events and Serious Adverse Events
Measured: 52 days
Safety as assessed by the incidence of adverse events of special interest:
Adverse Events of Special Interest to be assessed:
- Incidence of hospitalizations
- incidence of cytokine release syndrome
- hemophagocytic lymphohistiocytosis
- acute respiratory distress syndrome
- need for oxygen supplementation
Measured: 52 days
Tolerability as assessed by changes in vital signs from baseline (Day 1)
Changes as assessed by respiration rate
Measured: 22 days
Tolerability as assessed by changes in vital signs from baseline (Day 1)
Changes as assessed by heart rate
Measured: 22 days
Tolerability as assessed by changes in vital signs from baseline (Day 1)
Changes as assessed by oxygen saturation
Measured: 22 days
Tolerability as assessed by changes in vital signs from baseline (Day 1)
Changes as assessed by temperature
Measured: 22 days
Tolerability as assessed by changes in vital signs from baseline (Day 1)
Changes as assessed by blood pressure
Measured: 22 days
Tolerability as assessed by changes in clinical symptoms from baseline (Day 1)
Changes as assessed by physical exam
Measured: 22 days
Tolerability as assessed by changes in clinical laboratory tests from baseline (Day 1)
Changes as assessed by serum chemistry
Measured: 22 days
Tolerability as assessed by changes in clinical laboratory tests from baseline (Day 1)
Changes as assessed by hematology
Measured: 22 days
Tolerability as assessed by changes in clinical laboratory tests from baseline (Day 1)
Changes as assessed by coagulation
Measured: 22 days
Tolerability as assessed by changes in clinical laboratory tests from baseline (Day 1)
Changes as assessed by urinalysis
Measured: 22 days
Secondary outcomes (5)
Time to viral load undetectability;
Defined as the time to the first of 2 consecutive negative SARS-CoV-2 measurements assessed from swab specimen
Measured: 22 days
Proportion of patients with SARS-CoV-2 viral load below the level of detectability;
Assessed by swab specimen
Measured: 22 days
Mean change in SARS-CoV-2 viral load;
Assessed by swab specimen
Measured: 22 days
The time to clinical resolution;
Defined as resolution of symptoms on the WHO 9-point ordinal scale for clinical improvement.
Measured: 52 days
Zotatifin plasma concentrations
Concentrations at end of infusion, end of dosing interval, and on defined timepoint periods.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start1 Jul 2021
- Primary completion12 Jan 2023
- Study completion22 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corona Virus 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Patients will be randomized 3:1 to receive zotatifin or placebo in 3 cohorts of 12 patients each. Cohorts will be sequentially enrolled at progressively higher zotatifin dose levels: 0.01, 0.02, or 0.035 mg/kg.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Effector Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Responsible party
- Sponsor
- Investigators
- Douglas Warner, MD, Study director, EFFECTOR Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632381
- Sponsor's protocol ID
- eFT226-0003
- Acronym
- PROPEL
- Status last verified
- Oct 2023
- First submitted
- 12 Nov 2020
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Following completion of the study, the data may be considered for publication.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Trial of Intravenous Zotatifin in Adults With Mild or Moderate Coronavirus Disease 2019 (COVID-19)
- ClinicalTrials.gov ID
- NCT04632381
- Acronym / sponsor ID
- PROPEL / eFT226-0003
- Conditions
- Corona Virus Infection
- Keywords
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Effector TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 12 Jan 2023 (actual)
- Study completion
- 22 Sep 2023 (actual)
- First posted
- 17 Nov 2020 (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.
To evaluate the safety and tolerability, the antiviral activity, and plasma pharmacokinetics (PK) of zotatifin administered intravenously (IV) to adults with mild or moderate COVID-19.
Detailed description
This randomized, double-blind, placebo-controlled, dose-escalating study will evaluate the safety and efficacy of zotatifin administered IV to adults with mild or moderate COVID 19.
Patients will be randomized to receive zotatifin or placebo in 3 cohorts of 12 patients each. Cohorts will be sequentially enrolled at progressively higher zotatifin dose levels. Study drug will not be administered to patients who are hospitalized. The second dose of study drug will not be administered should a patient progress from mild or moderate COVID-19 to severe COVID-19 prior to or on Day 8. Patients will assess and record their symptoms daily through Day 22 and at follow up (30 days after last infusion) (or at the early termination visit [if conducted]) in a paper patient diary using the WHO 9-point ordinal scale for clinical improvement. Other safety and efficacy measures will be assessed according to the Schedule of Procedures on Days 1, 4, 8, 10, 15 (end of treatment visit), and 22, and at follow up (30 days after last infusion). On non-dosing days, study visits will be conducted as home health visits, except for the follow-up visit, which will be conducted as a telephone visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Patients will be randomized 3:1 to receive zotatifin or placebo in 3 cohorts of 12 patients each. Cohorts will be sequentially enrolled at progressively higher zotatifin dose levels: 0.01, 0.02, or 0.035 mg/kg.
| Arm | Type | Receives |
|---|---|---|
| Active Arm, Zota Cohort 1 | Active comparator | Drug: Zotatifin0.01 mg/kg zotatifin |
| Active Arm, Zota Cohort 2 | Active comparator | Drug: Zotatifin0.02 mg/kg zotatifin |
| Active Arm, Zota Cohort 3 | Active comparator | Drug: Zotatifin0.035 mg/kg zotatifin |
| Placebo | Placebo comparator | Drug: Placebo5% dextrose injection, USP |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (31 listed)
- Has provided informed consent and any authorizations required by local law;
- Is a male or female patient ≥18 and <65 years of age;
- Has a laboratory-documented positive test for SARS CoV 2 infection as determined by local laboratory using a standard, Food and Drug Administration (FDA)-approved viral RNA or viral antigen assay from any oral or respiratory sample collected within 48 hours of randomization;
- Has at least 2 symptoms associated with COVID-19 (fever or chills, cough, shortness of breath or difficulty breathing on exertion, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea) starting no more than 5 days prior to randomization and has mild or moderate disease at screening and at time of randomization, defined as the following:
- Has adequate hepatic function during screening, defined as the following:
Key exclusion criteria (24 listed)
- Is hospitalized for COVID-19;
- Has dyspnea at rest or while talking, or has signs and symptoms of overt or impending respiratory failure;
- Has significant cardiovascular disease, defined by myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism, within 3 months prior to randomization; symptomatic dysrhythmias or unstable dysrhythmias requiring medical therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association Class 3 or 4 congestive heart failure; ≥Grade 3 hypertension (diastolic blood pressure ≥100 mmHg or systolic blood pressure ≥160 mmHg); or history of congenital prolonged QT syndrome;
- Has a history of chronic obstructive pulmonary disease or bronchial asthma requiring continuous treatment and/or intermittent or continuous oxygen within the 90 days prior to screening; Note: Intermittent use of a β2-agonist inhaler is allowed.
- Has evidence of an ongoing or systemic bacterial, fungal, or viral infection (including upper respiratory tract infections) other than SARS-CoV-2 infection, recurrent or repeat SARS CoV 2 infection, or history of incompletely treated tuberculosis (TB) and/or suspected or known extrapulmonary TB; Note: Patients with localized fungal infections of the skin or nails are eligible. Patients may be receiving topical antifungals. Systemic administration of azole antifungals is prohibited (see Section 5.6).
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 |
|---|---|---|
| ZotatifinAlso: ZotaZotatifin is a potent and sequence-selective inhibitor of eukaryotic translation initiation factor (eIF) 4A1-mediated translation that imparts its regulation through a reversible enhancement of eIF4A1 binding to RNAs (ribonucleic acids) with specific polypurine motifs within the 5'-untranslated region (UTR). | Drug | Active Arm, Zota Cohort 1, Active Arm, Zota Cohort 2, Active Arm, Zota Cohort 3 |
| PlaceboAlso: PBO5% dextrose injection, USP | Drug | Placebo |
Primary outcome
Safety as assessed by the incidence of Treatment Emergent Adverse Events and Serious Adverse Events
Time frame: 52 days
Incidence of Treatment Emergent Adverse Events and Serious Adverse Events
Safety as assessed by the incidence of adverse events of special interest:
Time frame: 52 days
Adverse Events of Special Interest to be assessed: * Incidence of hospitalizations * incidence of cytokine release syndrome * hemophagocytic lymphohistiocytosis * acute respiratory distress syndrome * need for oxygen supplementation
Tolerability as assessed by changes in vital signs from baseline (Day 1)
Time frame: 22 days
Changes as assessed by respiration rate
Tolerability as assessed by changes in vital signs from baseline (Day 1)
Time frame: 22 days
Changes as assessed by heart rate
Tolerability as assessed by changes in vital signs from baseline (Day 1)
Time frame: 22 days
Changes as assessed by oxygen saturation
Tolerability as assessed by changes in vital signs from baseline (Day 1)
Time frame: 22 days
Changes as assessed by temperature
Tolerability as assessed by changes in vital signs from baseline (Day 1)
Time frame: 22 days
Changes as assessed by blood pressure
Tolerability as assessed by changes in clinical symptoms from baseline (Day 1)
Time frame: 22 days
Changes as assessed by physical exam
Tolerability as assessed by changes in clinical laboratory tests from baseline (Day 1)
Time frame: 22 days
Changes as assessed by serum chemistry
Tolerability as assessed by changes in clinical laboratory tests from baseline (Day 1)
Time frame: 22 days
Changes as assessed by hematology
Tolerability as assessed by changes in clinical laboratory tests from baseline (Day 1)
Time frame: 22 days
Changes as assessed by coagulation
Tolerability as assessed by changes in clinical laboratory tests from baseline (Day 1)
Time frame: 22 days
Changes as assessed by urinalysis
5 secondary outcomes
Time to viral load undetectability;
Time frame: 22 days
Proportion of patients with SARS-CoV-2 viral load below the level of detectability;
Time frame: 22 days
Mean change in SARS-CoV-2 viral load;
Time frame: 22 days
The time to clinical resolution;
Time frame: 52 days
Zotatifin plasma concentrations
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Link to the study website; Propel Covid-19 Clinical TrialLink provided by the sponsor.
- Individual participant dataSharing planned: No. Following completion of the study, the data may be considered for publication.
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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.
Douglas Warner, MD study director
EFFECTOR Therapeutics, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zotatifin in people with Corona Virus Infection, run by Effector Therapeutics at 4 sites in United States.
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 31 inclusion and 24 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: finished, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety as assessed by the incidence of Treatment Emergent Adverse Events and Serious Adverse Events (time frame: 52 days). The study lists 12 primary outcomes in all. 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 5 Oct 2023.