COVID-19 DiseasePhase 2NCT04446377
A Study of LAM-002A for the Prevention of Progression of COVID-19
A Phase 2 study testing Apilimod Dimesylate Capsule in people with COVID-19 Disease, run by IRulya Therapeutics Inc. at 1 site in United States.
Trial summary
This is a clinical trial to evaluate the efficacy of LAM-002A compared to placebo treatment in adults with a confirmed SARS-CoV-2 infection who are receiving standards supportive care in an outpatient setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Disease
- What is being tested?
- Apilimod Dimesylate Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2020to 19 Apr 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written documentation of SARS-CoV-2 infection confirmed by a validated test.
- Presence of greater than or equal to ≥1 of the following COVID-19-related symptoms indicating mild disease: fever (temperature ≥100.4), anosmia (loss of taste or smell), cough, sore throat, gastrointestinal complaints (e.g. nausea, vomiting, or diarrhea), chills, congestion, or runny nose, headaches, muscle or body aches, fatigue, or asymptomatic patients who have tested positive for COVID-19 via a validated test within the past 4 days.
- If symptomatic, symptom onset less than or equal to ≤ 8 days.
- For female participants of childbearing potential, a negative urine (or serum) pregnancy test.
- For female participants of childbearing potential, willingness to use a protocol-recommended method of contraception from the start of the screening period until greater than or equal to ≥30 days after the final dose of study therapy. Note: A female subject 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 [FSH] levels within the institutional laboratory postmenopausal range and a negative serum or urine beta human chorionic gonadotropin [βHCG]); or is menopausal (age ≥50 years with amenorrhea for ≥6 months).
- For male participants who can father a child and are having intercourse with females of childbearing potential who are not using adequate contraception, willingness to use a protocol-recommended method of contraception from the start of study therapy until ≥30 days after the final dose of study therapy and to refrain from sperm donation from the start of study therapy until ≥90 days after administration of the final dose of study therapy. Note: A male subject is considered able to father a child unless he has had a bilateral vasectomy with documented aspermia or a bilateral orchiectomy.
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- Willingness and ability of the participant to ingest study drug capsules.
- Willingness of the participant to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, study procedures, and study restrictions.
- Evidence of a personally signed informed consent indicating that the participant is aware of the nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.
Who cannot join
- Respiratory rate greater than or equal to ≥20 breaths per minute.
- Oxygen saturation by pulse oximetry less than or equal to ≤93 percent % on room air or requirement for supplemental oxygen to maintain oxygen saturation greater than >93 percent %.
- Total NEWS score greater than or equal to ≥6 or presence of a score of 3 on any of the individual NEWS parameters.
- Radiographic evidence of pulmonary infiltrates (clinical X-ray within 2 days of referral)
- Hepatic profile showing any of the following:
- Serum alanine aminotransferase (ALT) greater than >5 × upper limit of normal (ULN) (CTCAE Grade greater than or equal to ≥3).
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- Serum aspartate aminotransferase (AST) greater than >5 × ULN (CTCAE Grade greater than or equal to ≥3).
- Serum bilirubin greater than >1.5 × ULN (CTCAE Grade greater than or equal to ≥2).
- Renal profile showing an estimated creatinine clearance (eClCR) less than <30 mL/minute (with eClCR to be calculated by the method at the laboratory performing the serum creatinine test).
- Presence of a cancer with disease manifestations or therapy that could adversely affect subject safety or longevity, create the potential for drug-drug interactions, or compromise the interpretation of study results.
- Significant cardiovascular disease (e.g. myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 1 month prior to start of study therapy; unstable angina; symptomatic peripheral vascular disease; CTCAE Grade greater than or equal to ≥2 congestive heart failure; or uncontrolled CTCAE Grade greater than or equal to ≥3 hypertension (diastolic blood pressure greater than or equal to ≥100 mmHg or systolic blood pressure greater than or equal to ≥160 mmHg) despite antihypertensive therapy.
- Significant screening ECG abnormalities, including atrial fibrillation/flutter, 2nd degree atrioventricular (AV) block type II, 3rd-degree AV block, Grade greater than or equal to ≥2 bradycardia, or corrected QT (QTc by Fridericia [QTcF]) greater than >480 msec (Grade greater than >1).
- Gastrointestinal disease (e.g. gastric or intestinal bypass surgery, pancreatic enzyme insufficiency, malabsorption syndrome, symptomatic inflammatory bowel disease, chronic diarrheal illness, bowel obstruction) that might interfere with drug absorption or with interpretation of gastrointestinal AEs.
- Pregnancy or breastfeeding.
- Prior solid organ transplantation.
- Use within 5 days prior to randomization of an approved or investigational therapy intended to treat COVID-19 (e.g. remdesivir, , anti-interleukin [IL]-6 antibodies, therapeutic anti-SARS CoV-2 antibodies or post-convalescent plasma, anti- SARS CoV-2 vaccine, Bruton tyrosine kinase [BTK] inhibitor), use within 3 months of chloroquine or hydroxychloroquine. Note: participants are not precluded from undergoing evaluations involving observation, noninvasive diagnostic procedures or sampling, or questionnaires as follow-up to a prior study or as components of a concurrent noninterventional study.
- Use within 5 days prior to randomization of a strong inhibitor or inducer of cytochrome P450 (CYP) 3A4 or expected requirement for chronic use of a strong inhibitor or inducer of CYP3A4 during study therapy.
- Use within 5 days prior to randomization of drug that is a moderate-to-strong substrate of CYP2C9 (including warfarin, tolbutamide, phenytoin, glimepiride) or expected requirement for chronic use of such drugs during study therapy.
- Use within 5 days prior to randomization of a drug known to prolong the QT interval
- Ongoing immunosuppressive therapy including systemic or enteric corticosteroids. (Note: At study entry, participants may be using intraarticular, inhaled, or topical corticosteroids. During study therapy, participants may use systemic, enteric, intraarticular, inhaled, or topical corticosteroids as required for intercurrent conditions.)
- 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 participant's ability to provide informed consent, adversely affect the participant's ability to cooperate and participate in the study, or compromise the interpretation of study results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Randomized, Double-Blind, Placebo-Controlled Study of LAM-002A for the Prevention of Progression of COVID-19
This is a clinical trial to evaluate the efficacy of LAM-002A compared to placebo treatment in adults with a confirmed SARS-CoV-2 infection who are receiving standards supportive care in an outpatient setting.
Read the detailed description
This is a Phase II randomized, double-blind, placebo-controlled, clinical study to evaluate the efficacy of LAM-002A compared to placebo treatment in adults with a confirmed SARS-CoV-2 infection who are receiving standard supportive care in an outpatient setting.
Study eligibility will be assessed during screening. All study participants must sign a written informed consent and satisfy the inclusion and exclusion criteria for the study. Confirmation of SARS-CoV-2 infection, medical history, and current medication will be assessed for each consenting participant at screening.
Study participants will be randomized in a 1:1 ratio, to receive study therapy (either LAM-002A, 125 mg [5 capsules/dose]) PO BID or placebo [5 capsules/dose] PO BID) for 10 days. Participants who experience an adverse event (AE) considered to be related to study therapy may have a decrease in study dose of LAM-002A to 100 mg [4 capsules/dose]) PO BID or placebo [4 capsules/dose] PO BID). After the start of treatment on Day 1, participants will be followed at Days 4,6,8,11,22, and 28. Days 6,8, and 22 will be phone visits. Participants can withdraw from the study therapy or study participation at any time.
The study will incorporate an interim safety analysis after the first 30 participants (15 on LAM-002A and 15 on placebo) have completed treatment and have been followed up for 11 days post-first dose. Recruitment and randomization will continue while this analysis is conducted. Recommendations from an independent Data Safety Monitoring Board (DSMB) will be used for decisions of early termination or study design adaptations.
Non-parametric and parametric statistical analysis will be conducted, as appropriate. For the comparison of the LAM-002A active arm and the control arm for the primary endpoint and secondary endpoints of drug effect, appropriate methods will be employed. Baseline subject characteristics, study therapy administration/compliance, safety, supportive care administration, and pharmacokinetics will be analyzed descriptively.
- Conditions
- COVID-19 Disease
- Being tested
- Apilimod Dimesylate Capsule, Placebo
- Keywords
- COVID-19, SARS-CoV-2, Apilimod Dimesylate, LAM-002A, Coronavirus, AI Therapeutics
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apilimod Dimesylate CapsuleDrug
LAM-002A is formulated in capsules containing 25 mg of apilimod dimesylate. The capsule is Swedish orange, Size 0.
PlaceboOther
Microcrystalline cellulose in Swedish orange, Size 0 capsules
| Study group | Role | What they receive |
|---|---|---|
| LAM-002A | Experimental | LAM-002A (Apilimod Dimesylate) 125mg in five 25-mg capsules BID for 10 days Receives: Drug: Apilimod Dimesylate Capsule |
| Placebo | Placebo comparator | (microcrystalline cellulose) in 5 capsules BID for 10 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral Load Change
The primary efficacy outcome measure evaluated change in SARS-CoV-2 viral load at Day 4 from Day 1, of LAM-002A or placebo-treated participants. SARS-CoV-2 viral load was measured by a real-time quantitative reverse transcription polymerase chain reaction (qRT-PCR) test of nasopharyngeal samples. Analysis focused on log10 viral load on Day 4 compared to baseline viral load at Day 1 in participants with baseline viral load >100,000 copies/mL
Measured: 4 Days
Secondary outcomes (4)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
The number and percentage of LAM 002A-treated participants who developed TEAEs compared to placebo
Measured: 28 Days
Clinical Efficacy
Number of Participants with Hospitalization or Death within 28 days
Measured: 28 Days
Change in COVID-19 Clinical Status
To evaluate change in COVID-19 clinical status, as defined by the ordinal scale, of participants treated with LAM-002A compared to placebo at Day 28, in participants who became hospitalized and continued LAM-002A/placebo treatment, based on the following scores:
- Not in the hospital
- Hospitalized, requiring low flow supplemental oxygen (such as nasal cannula)
- Hospitalized, not on invasive ventilation (such as 100% non-rebreather, BIPAP), (pre-ICU)
- Hospitalized, in the ICU, on invasive ventilation or Extracorporeal membrane oxygenation (ECMO)
- Dead
Measured: 28 Days
Oxygen Saturation
Comparison of the number and percentage of participants with an oxygen saturation (O2 sat) ≥95% between LAM-002A versus placebo treatment groups.
Measured: Baseline, Day 1, Day 4, Day 11, Day28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start15 Jul 2020
- Primary completion24 Mar 2021
- Study completion19 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRulya Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yale University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446377
- Sponsor's protocol ID
- LAM-002A-CVD-CLN01
- Status last verified
- Aug 2023
- First submitted
- 23 Jun 2020
- Last updated
- 8 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kumar P, Mathayan M, Smieszek SP, Przychodzen BP, Koprivica V, Birznieks G, Polymeropoulos MH, Prabhakar BS. Identification of potential COVID-19 treatment compounds which inhibit SARS Cov2 prototypic, Delta and Omicron variant infection. Virology. 2022 Jul;572:64-71. doi: 10.1016/j.virol.2022.05.004. Epub 2022 May 16.
PubMed 35598394
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Double-Blind, Placebo-Controlled Study of LAM-002A for the Prevention of Progression of COVID-19
- ClinicalTrials.gov ID
- NCT04446377
- Acronym / sponsor ID
- LAM-002A-CVD-CLN01
- Conditions
- COVID-19 Disease
- Keywords
- COVID-19, SARS-CoV-2, Apilimod Dimesylate, LAM-002A, Coronavirus, AI Therapeutics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- IRulya Therapeutics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Yale University
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 24 Mar 2021 (actual)
- Study completion
- 19 Apr 2021 (actual)
- First posted
- 24 Jun 2020 (actual)
- Results
- Posted 8 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a clinical trial to evaluate the efficacy of LAM-002A compared to placebo treatment in adults with a confirmed SARS-CoV-2 infection who are receiving standards supportive care in an outpatient setting.
Detailed description
This is a Phase II randomized, double-blind, placebo-controlled, clinical study to evaluate the efficacy of LAM-002A compared to placebo treatment in adults with a confirmed SARS-CoV-2 infection who are receiving standard supportive care in an outpatient setting.
Study eligibility will be assessed during screening. All study participants must sign a written informed consent and satisfy the inclusion and exclusion criteria for the study. Confirmation of SARS-CoV-2 infection, medical history, and current medication will be assessed for each consenting participant at screening.
Study participants will be randomized in a 1:1 ratio, to receive study therapy (either LAM-002A, 125 mg [5 capsules/dose]) PO BID or placebo [5 capsules/dose] PO BID) for 10 days. Participants who experience an adverse event (AE) considered to be related to study therapy may have a decrease in study dose of LAM-002A to 100 mg [4 capsules/dose]) PO BID or placebo [4 capsules/dose] PO BID). After the start of treatment on Day 1, participants will be followed at Days 4,6,8,11,22, and 28. Days 6,8, and 22 will be phone visits. Participants can withdraw from the study therapy or study participation at any time.
The study will incorporate an interim safety analysis after the first 30 participants (15 on LAM-002A and 15 on placebo) have completed treatment and have been followed up for 11 days post-first dose. Recruitment and randomization will continue while this analysis is conducted. Recommendations from an independent Data Safety Monitoring Board (DSMB) will be used for decisions of early termination or study design adaptations.
Non-parametric and parametric statistical analysis will be conducted, as appropriate. For the comparison of the LAM-002A active arm and the control arm for the primary endpoint and secondary endpoints of drug effect, appropriate methods will be employed. Baseline subject characteristics, study therapy administration/compliance, safety, supportive care administration, and pharmacokinetics will be analyzed descriptively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LAM-002A | Experimental | Drug: Apilimod Dimesylate CapsuleLAM-002A (Apilimod Dimesylate) 125mg in five 25-mg capsules BID for 10 days |
| Placebo | Placebo comparator | Other: Placebo(microcrystalline cellulose) in 5 capsules BID for 10 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written documentation of SARS-CoV-2 infection confirmed by a validated test.
- Presence of greater than or equal to ≥1 of the following COVID-19-related symptoms indicating mild disease: fever (temperature ≥100.4), anosmia (loss of taste or smell), cough, sore throat, gastrointestinal complaints (e.g. nausea, vomiting, or diarrhea), chills, congestion, or runny nose, headaches, muscle or body aches, fatigue, or asymptomatic patients who have tested positive for COVID-19 via a validated test within the past 4 days.
- If symptomatic, symptom onset less than or equal to ≤ 8 days.
- For female participants of childbearing potential, a negative urine (or serum) pregnancy test.
- For female participants of childbearing potential, willingness to use a protocol-recommended method of contraception from the start of the screening period until greater than or equal to ≥30 days after the final dose of study therapy. Note: A female subject 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 [FSH] levels within the institutional laboratory postmenopausal range and a negative serum or urine beta human chorionic gonadotropin [βHCG]); or is menopausal (age ≥50 years with amenorrhea for ≥6 months).
Key exclusion criteria (21 listed)
- Respiratory rate greater than or equal to ≥20 breaths per minute.
- Oxygen saturation by pulse oximetry less than or equal to ≤93 percent % on room air or requirement for supplemental oxygen to maintain oxygen saturation greater than >93 percent %.
- Total NEWS score greater than or equal to ≥6 or presence of a score of 3 on any of the individual NEWS parameters.
- Radiographic evidence of pulmonary infiltrates (clinical X-ray within 2 days of referral)
- Hepatic profile showing any of the following:
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 |
|---|---|---|
| Apilimod Dimesylate CapsuleLAM-002A is formulated in capsules containing 25 mg of apilimod dimesylate. The capsule is Swedish orange, Size 0. | Drug | LAM-002A |
| PlaceboMicrocrystalline cellulose in Swedish orange, Size 0 capsules | Other | Placebo |
Primary outcome
Viral Load Change
Time frame: 4 Days
The primary efficacy outcome measure evaluated change in SARS-CoV-2 viral load at Day 4 from Day 1, of LAM-002A or placebo-treated participants. SARS-CoV-2 viral load was measured by a real-time quantitative reverse transcription polymerase chain reaction (qRT-PCR) test of nasopharyngeal samples. Analysis focused on log10 viral load on Day 4 compared to baseline viral load at Day 1 in participants with baseline viral load >100,000 copies/mL
4 secondary outcomes
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: 28 Days
Clinical Efficacy
Time frame: 28 Days
Change in COVID-19 Clinical Status
Time frame: 28 Days
Oxygen Saturation
Time frame: Baseline, Day 1, Day 4, Day 11, Day28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35598394Kumar P, Mathayan M, Smieszek SP, Przychodzen BP, Koprivica V, Birznieks G, Polymeropoulos MH, Prabhakar BS. Identification of potential COVID-19 treatment compounds which inhibit SARS Cov2 prototypic, Delta and Omicron variant infection. Virology. 2022 Jul;572:64-71. doi: 10.1016/j.virol.2022.05.004. Epub 2022 May 16.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apilimod Dimesylate Capsule in people with COVID-19 Disease, run by IRulya Therapeutics Inc. at 1 site 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 9 inclusion and 21 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 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Viral Load Change (time frame: 4 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04446377, which also lists 1 linked publication.
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 8 Aug 2023.