A Study of LAM-002A for the Prevention of Progression of COVID-19
A Phase II Randomized, Double-Blind, Placebo-Controlled Study of LAM-002A for the Prevention of Progression of COVID-19
1 other identifier
interventional
142
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2020
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2020
CompletedFirst Posted
Study publicly available on registry
June 24, 2020
CompletedStudy Start
First participant enrolled
July 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 24, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2021
CompletedResults Posted
Study results publicly available
August 8, 2023
CompletedAugust 8, 2023
August 1, 2023
8 months
June 23, 2020
May 19, 2023
August 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
4 Days
Secondary Outcomes (4)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
28 Days
Clinical Efficacy
28 Days
Change in COVID-19 Clinical Status
28 Days
Oxygen Saturation
Baseline, Day 1, Day 4, Day 11, Day28
Other Outcomes (1)
Number and Percentage of Participants With Viral Load < Lower Limit of Quantification (LLOQ)
4 Days
Study Arms (2)
LAM-002A
EXPERIMENTALLAM-002A (Apilimod Dimesylate) 125mg in five 25-mg capsules BID for 10 days
Placebo
PLACEBO COMPARATOR(microcrystalline cellulose) in 5 capsules BID for 10 days
Interventions
LAM-002A is formulated in capsules containing 25 mg of apilimod dimesylate. The capsule is Swedish orange, Size 0.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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).
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OrphAI Therapeuticslead
- Yale Universitycollaborator
Study Sites (1)
Yale University
New Haven, Connecticut, 06510, United States
Related Publications (1)
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.
PMID: 35598394DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was potentially limited in its ability to discern a benefit of LAM-002A on viral and clinical endpoints due to the number of participants enrolled, the low baseline viral loads, and the short (4-day) duration of viral load evaluation.
Results Point of Contact
- Title
- Peter R. Young/Chief Scientific Officer
- Organization
- AI Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2020
First Posted
June 24, 2020
Study Start
July 15, 2020
Primary Completion
March 24, 2021
Study Completion
April 19, 2021
Last Updated
August 8, 2023
Results First Posted
August 8, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share