Trial Outcomes & Findings for A Study of LAM-002A for the Prevention of Progression of COVID-19 (NCT NCT04446377)

Last Updated: 2023-08-08

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

142 participants

Primary outcome timeframe

4 Days

Results posted on

2023-08-08

Participant Flow

This study was conducted by 8 investigators located at medical centers throughout the United States

The screening and baseline visits could occur on the same day. Day 1 of the study was the day the participant took the first dose of study drug after randomization.

Participant milestones

Participant milestones
Measure	LAM-002A 71 participants were allocated to receive LAM-002A (Apilimod Dimesylate) 125 mg in five 25-mg capsules twice a day (BID) for 10 days. Participants were to be followed for 28 days from the start of LAM-002A treatment.	Placebo 71 participants were allocated to receive Placebo (microcrystalline cellulose) in 5 capsules BID for 10 days. Participants were to be followed for 28 days from the start of Placebo treatment.
Overall Study STARTED	71	71
Overall Study COMPLETED	64	66
Overall Study NOT COMPLETED	7	5

Reasons for withdrawal

Reasons for withdrawal
Measure	LAM-002A 71 participants were allocated to receive LAM-002A (Apilimod Dimesylate) 125 mg in five 25-mg capsules twice a day (BID) for 10 days. Participants were to be followed for 28 days from the start of LAM-002A treatment.	Placebo 71 participants were allocated to receive Placebo (microcrystalline cellulose) in 5 capsules BID for 10 days. Participants were to be followed for 28 days from the start of Placebo treatment.
Overall Study Withdrawal by Subject	6	1
Overall Study Physician Decision	1	1
Overall Study Lost to Follow-up	0	2
Overall Study Not eligible	0	1

Baseline Characteristics

A Study of LAM-002A for the Prevention of Progression of COVID-19

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LAM-002A n=71 Participants 71 subjects were allocated to receive LAM-002A (Apilimod Dimesylate) 125 mg in five 25-mg capsules BID for 10 days.	Placebo n=71 Participants 71 subjects were allocated to receive Placebo (microcrystalline cellulose) in 5 capsules BID for 10 days.	Total n=142 Participants Total of all reporting groups
Age, Continuous	42.8 years n=5 Participants	43.3 years n=7 Participants	43.1 years n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	37 Participants n=7 Participants	74 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	34 Participants n=7 Participants	68 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	25 Participants n=5 Participants	27 Participants n=7 Participants	52 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=5 Participants	44 Participants n=7 Participants	89 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Patient Race · White	64 Participants n=5 Participants	61 Participants n=7 Participants	125 Participants n=5 Participants
Race/Ethnicity, Customized Patient Race · Black or African American	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Patient Race · Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Patient Race · Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Patient Race · Unknown	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	71 participants n=5 Participants	71 participants n=7 Participants	142 participants n=5 Participants
ECOG Performance Status 0: Fully active	55 Participants n=5 Participants	59 Participants n=7 Participants	114 Participants n=5 Participants
ECOG Performance Status 1: Restricted	16 Participants n=5 Participants	11 Participants n=7 Participants	27 Participants n=5 Participants
ECOG Performance Status 2: Ambulatory	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Oxygen Saturation	98.0 percent n=5 Participants	98.0 percent n=7 Participants	98.0 percent n=5 Participants
Temperature	36.8 degrees Celsius n=5 Participants	36.8 degrees Celsius n=7 Participants	36.8 degrees Celsius n=5 Participants

PRIMARY outcome

Timeframe: 4 Days

Population: Antiviral efficacy population comprising of participants with baseline viral load \>100,000 copies/mL = log10 viral load \>5)

Outcome measures

Outcome measures
Measure	LAM-002A n=43 Participants 71 participants were allocated to receive LAM-002A (Apilimod Dimesylate) 125 mg in five 25-mg capsules BID for 10 days.	Placebo n=35 Participants 71 participants were allocated to receive Placebo (microcrystalline cellulose) in 5 capsules BID for 10 days.
Viral Load Change	-2.50 log10 copies/mL Standard Deviation 2.35	-1.99 log10 copies/mL Standard Deviation 1.71

SECONDARY outcome

Timeframe: 28 Days

Population: All participants who received at least 1 dose of study treatment

The number and percentage of LAM 002A-treated participants who developed TEAEs compared to placebo

Outcome measures

Outcome measures
Measure	LAM-002A n=71 Participants 71 participants were allocated to receive LAM-002A (Apilimod Dimesylate) 125 mg in five 25-mg capsules BID for 10 days.	Placebo n=70 Participants 71 participants were allocated to receive Placebo (microcrystalline cellulose) in 5 capsules BID for 10 days.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	26 Participants	14 Participants

SECONDARY outcome

Timeframe: 28 Days

Population: The intention-to-treat (ITT) population included all participants randomized according to their initial randomized assignment regardless of the treatment actually received.

Number of Participants with Hospitalization or Death within 28 days

Outcome measures

Outcome measures
Measure	LAM-002A n=71 Participants 71 participants were allocated to receive LAM-002A (Apilimod Dimesylate) 125 mg in five 25-mg capsules BID for 10 days.	Placebo n=71 Participants 71 participants were allocated to receive Placebo (microcrystalline cellulose) in 5 capsules BID for 10 days.
Clinical Efficacy Yes	2 Participants	1 Participants
Clinical Efficacy No	69 Participants	70 Participants

SECONDARY outcome

Timeframe: 28 Days

Population: The intention-to-treat (ITT) population included all participants randomized according to their initial randomized assignment regardless of the treatment actually received. \* Participant 008-109 in the LAM-002A group was in the hospital at Day 28, but her score is missing, this participant died in the hospital on Day 30.

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

Outcome measures

Outcome measures
Measure	LAM-002A n=71 Participants 71 participants were allocated to receive LAM-002A (Apilimod Dimesylate) 125 mg in five 25-mg capsules BID for 10 days.	Placebo n=71 Participants 71 participants were allocated to receive Placebo (microcrystalline cellulose) in 5 capsules BID for 10 days.
Change in COVID-19 Clinical Status 1: Not in the hospital	64 Participants	66 Participants
Change in COVID-19 Clinical Status 2: Hospitalized, requiring low flow supplemental oxygen (such as nasal cannula)	0 Participants	0 Participants
Change in COVID-19 Clinical Status 3: Hospitalized, not on invasive ventilation (such as 100% non-rebreather, BIPAP), (pre-ICU)	0 Participants	0 Participants
Change in COVID-19 Clinical Status 4: Hospitalized, in the ICU, on invasive ventilation or ECMO	0 Participants	0 Participants
Change in COVID-19 Clinical Status 5: Dead	0 Participants	0 Participants
Change in COVID-19 Clinical Status Status Unknown*	7 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline, Day 1, Day 4, Day 11, Day28

Population: The intention-to-treat (ITT) population included all participants randomized according to their initial randomized assignment regardless of the treatment actually received.

Comparison of the number and percentage of participants with an oxygen saturation (O2 sat) ≥95% between LAM-002A versus placebo treatment groups.

Outcome measures

Outcome measures
Measure	LAM-002A n=71 Participants 71 participants were allocated to receive LAM-002A (Apilimod Dimesylate) 125 mg in five 25-mg capsules BID for 10 days.	Placebo n=71 Participants 71 participants were allocated to receive Placebo (microcrystalline cellulose) in 5 capsules BID for 10 days.
Oxygen Saturation Baseline, oxygen saturation ≥95% · Yes	67 Participants	68 Participants
Oxygen Saturation Baseline, oxygen saturation ≥95% · No	4 Participants	3 Participants
Oxygen Saturation Day 1, oxygen saturation ≥95% · Yes	60 Participants	59 Participants
Oxygen Saturation Day 1, oxygen saturation ≥95% · No	2 Participants	2 Participants
Oxygen Saturation Day 4, oxygen saturation ≥95% · Yes	59 Participants	65 Participants
Oxygen Saturation Day 4, oxygen saturation ≥95% · No	9 Participants	3 Participants
Oxygen Saturation Day 11, oxygen saturation ≥95% · Yes	60 Participants	65 Participants
Oxygen Saturation Day 11, oxygen saturation ≥95% · No	4 Participants	2 Participants
Oxygen Saturation Day 28, oxygen saturation ≥95% · Yes	65 Participants	66 Participants
Oxygen Saturation Day 28, oxygen saturation ≥95% · No	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 Days

Population: Antiviral efficacy population comprising participants with baseline viral load \>100,000 copies/ml = log10 viral load \>5)

Evaluated the difference in the number and percentage of participants with a SARS-CoV-2 viral load \<LLOQ between the LAM-002A and the placebo arm as measured by a qRT-PCR test from nasopharyngeal samples at Day 4.

Outcome measures

Outcome measures
Measure	LAM-002A n=37 Participants 71 participants were allocated to receive LAM-002A (Apilimod Dimesylate) 125 mg in five 25-mg capsules BID for 10 days.	Placebo n=31 Participants 71 participants were allocated to receive Placebo (microcrystalline cellulose) in 5 capsules BID for 10 days.
Number and Percentage of Participants With Viral Load < Lower Limit of Quantification (LLOQ)	9 Participants	3 Participants

Adverse Events

LAM-002A

Serious events: 2 serious events

Other events: 26 other events

Deaths: 1 deaths

Placebo

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	LAM-002A n=71 participants at risk 71 participants received LAM-002A (Apilimod Dimesylate) 125 mg in five 25-mg capsules BID for 10 days.	Placebo n=70 participants at risk 70 participants received Placebo (microcrystalline cellulose) in 5 capsules BID for 10 days.
Infections and infestations COVID-19 pneumonia	1.4% 1/71 • Number of events 1 • Adverse events were collected from the first administration of study drug through Day 28 or when any ongoing drug-related adverse events (AEs) and/or serious adverse events (SAEs) resolved or became stable, up to 30 days. Adverse Events were analyzed for all participants who received at least 1 dose of study treatment. In the Placebo group, 1 subject did not initiate treatment.	0.00% 0/70 • Adverse events were collected from the first administration of study drug through Day 28 or when any ongoing drug-related adverse events (AEs) and/or serious adverse events (SAEs) resolved or became stable, up to 30 days. Adverse Events were analyzed for all participants who received at least 1 dose of study treatment. In the Placebo group, 1 subject did not initiate treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.4% 1/71 • Number of events 1 • Adverse events were collected from the first administration of study drug through Day 28 or when any ongoing drug-related adverse events (AEs) and/or serious adverse events (SAEs) resolved or became stable, up to 30 days. Adverse Events were analyzed for all participants who received at least 1 dose of study treatment. In the Placebo group, 1 subject did not initiate treatment.	1.4% 1/70 • Number of events 1 • Adverse events were collected from the first administration of study drug through Day 28 or when any ongoing drug-related adverse events (AEs) and/or serious adverse events (SAEs) resolved or became stable, up to 30 days. Adverse Events were analyzed for all participants who received at least 1 dose of study treatment. In the Placebo group, 1 subject did not initiate treatment.

Other adverse events

Additional Information

Peter R. Young/Chief Scientific Officer

AI Therapeutics

Phone: 203-458-7100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator agreed that the primary publication, will be coordinated by the sponsor, will be the first publication to present the pooled study results. After the primary publication, or if the primary publication is not published within 2 years of termination of the study, the investigator may freely publish or present the results of his or her work conducted under the clinical trial agreement, subject to providing the sponsor with the opportunity to review the contents.
Publication restrictions are in place

Restriction type: OTHER