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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
142
LAM-002A is formulated in capsules containing 25 mg of apilimod dimesylate. The capsule is Swedish orange, Size 0.
Microcrystalline cellulose in Swedish orange, Size 0 capsules
Yale University
New Haven, Connecticut, United States
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
Time frame: 4 Days
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
The number and percentage of LAM 002A-treated participants who developed TEAEs compared to placebo
Time frame: 28 Days
Clinical Efficacy
Number of Participants with Hospitalization or Death within 28 days
Time frame: 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: 1. Not in the hospital 2. Hospitalized, requiring low flow supplemental oxygen (such as nasal cannula) 3. Hospitalized, not on invasive ventilation (such as 100% non-rebreather, BIPAP), (pre-ICU) 4. Hospitalized, in the ICU, on invasive ventilation or Extracorporeal membrane oxygenation (ECMO) 5. Dead
Time frame: 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.
Time frame: Baseline, Day 1, Day 4, Day 11, Day28
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