NCT04523181

Double-blind Study to Evaluate the Safety and Efficacy of Antroquinonol in Mild-Moderate COVID-19 Hospitalized Patients

Completed Phase 2 Results posted Last updated 13 December 2023

What this trial tests

Phase 2 trial testing Antroquinonol in Covid-19 in 124 participants. Completed in 23 December 2021.

Timeline

15 October 2020

Primary endpoint
23 December 2021

23 December 2021

Quick facts

Lead sponsor	Golden Biotechnology Corporation
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	124
Start date	15 October 2020
Primary completion	23 December 2021
Estimated completion	23 December 2021
Sites	15 locations across Argentina, United States, Peru

Drugs / interventions tested

• Antroquinonol — full drug profile →
• Placebo

Conditions studied

• Covid-19 — all drugs for Covid-19 →

Sponsor

Golden Biotechnology Corporation

Who can join

Adults 18 to 80, any sex, with Covid-19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Recover Ratio Primary · 14 day

Number of Patients Who are Alive and Free of Respiratory Failure (e.g., no need for invasive mechanical ventilation, non invasive ventilation, high flow oxygen, or ECMO) on Day 14.

Alive and Free of Respiratory Failure

Group	Value	95% CI
Antroquinonol With SOC	47
Placebo With SOC	48

Respiratory Failure

Group	Value	95% CI
Antroquinonol With SOC	1
Placebo With SOC	0

Missing

Group	Value	95% CI
Antroquinonol With SOC	14
Placebo With SOC	14

Death

Group	Value	95% CI
Antroquinonol With SOC	0
Placebo With SOC	0

Time to 2-point Improvement, Score 2 or Lower, and Score 0 From Baseline on the WHO COVID-19 Clinical Improvement Ordinal Scale Secondary · 28-day

Time to 2-point improvement from baseline, time to score 2 and lower from baseline and time to score 0 from baseline are measured by WHO COVID-19 Clinical Improvement Ordinal Scale

Time to 2-point Improvement from Baseline

Group	Value	95% CI
Antroquinonol With SOC	7.0	5.0 – 15.0
Placebo With SOC	6.0	5.0 – 9.0

Time to Score 2 or Lower from Baseline

Group	Value	95% CI
Antroquinonol With SOC	6	4.0 – 10.0
Placebo With SOC	6	5.0 – 9.0

Time to Score 0 from Baseline

Group	Value	95% CI
Antroquinonol With SOC	29.0	29.0 – 30.0
Placebo With SOC	31	30.0 – 42.0

Duration of Hospitalization Secondary · 28 day

Duration of hospitalization is the total number of days the patient is hospitalized during their participation in the study, up to Day 28.

Overall

Group	Value	95% CI
Placebo With SOC	6.5	± 5.54
Antroquinonol With SOC	6.4	± 5.38

Age ≤65 Years Old

Group	Value	95% CI
Placebo With SOC	6.7	± 5.72
Antroquinonol With SOC	6.4	± 5.44

Age >65 Years Old

Group	Value	95% CI
Placebo With SOC	3.8	± 1.10
Antroquinonol With SOC	6.8	± 5.22

With COVID-19 Treatment at Baseline

Group	Value	95% CI
Placebo With SOC	6.1	± 5.71
Antroquinonol With SOC	5.1	± 3.44

Without COVID-19 Treatment at Baseline

Group	Value	95% CI
Placebo With SOC	6.9	± 5.38
Antroquinonol With SOC	9.0	± 7.25

Time to Virological Clearance Secondary · 28 day

measured as study days from start of treatment to first negative SARS CoV 2 PCR test

Group	Value	95% CI
Antroquinonol With SOC	14.0	6.0 – 15.0
Placebo With SOC	15.0	7.0 – 29.0

Number of Patients Who Recovered From Loss of Taste or Smell Secondary · 28 days

Patients with loss of taste or smell from baseline and back to normal during the observation period.

Group	Value	95% CI
Antroquinonol With SOC	10
Placebo With SOC	8

Adverse events — posted to ClinicalTrials.gov

Time frame: 4 Weeks. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Antroquinonol With SOC

Serious: 4/60 (7%)

Deaths: 0/62

Placebo With SOC

Serious: 1/62 (2%)

Deaths: 0/62

Serious adverse events (5 terms)

Reaction	System	Antroquinonol With SOC	Placebo With SOC
Skin ulcer	Skin and subcutaneous tissue disorders	—	—
Subcutaneous emphysema	Skin and subcutaneous tissue disorders	—	—
Immune thrombocytopenia	Blood and lymphatic system disorders	—	—
Cerebrovascular accident	Nervous system disorders	—	—
Asthma	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (78 terms — click to expand)

Reaction	System	Antroquinonol With SOC	Placebo With SOC
Nausea	Gastrointestinal disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Alanine aminotransferase increased	Investigations	—	—
Anxiety	Psychiatric disorders	—	—
Insomnia	Psychiatric disorders	—	—
Gamma-glutamyltransferase increased	Investigations	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Blood lactate dehydrogenase increased	Investigations	—	—
Transaminases increased	Investigations	—	—
Platelet count increased	Investigations	—	—
Rah	Skin and subcutaneous tissue disorders	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—
Dyspepsia	Gastrointestinal disorders	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—
Flatulence	Gastrointestinal disorders	—	—
Blood bicarbonate decreased	Investigations	—	—
Blood cholesterol decreased	Investigations	—	—
Glomerular filtration rate decreased	Investigations	—	—
Hepatic enzyme increased	Investigations	—	—
Liver function test increased	Investigations	—	—
Neutrophil count increased	Investigations	—	—
Blood bilirubin increased	Investigations	—	—
Blood pressure increased	Investigations	—	—
Haematocrit decreased	Investigations	—	—
Haemoglobin decreased	Investigations	—	—
Lymphocyte count decreased	Investigations	—	—
Protein total decreased	Investigations	—	—
Red blood cell count decreased	Investigations	—	—
White blood cell count increased	Investigations	—	—
Hyperhidrosis	Skin and subcutaneous tissue disorders	—	—
Night sweats	Skin and subcutaneous tissue disorders	—	—
Skin ulcer	Skin and subcutaneous tissue disorders	—	—
Subcutaneous emphysema	Skin and subcutaneous tissue disorders	—	—
Ecchymosis	Skin and subcutaneous tissue disorders	—	—
Umbilical discharge	Skin and subcutaneous tissue disorders	—	—
Cerebrovascular accident	Nervous system disorders	—	—
Head discomfort	Nervous system disorders	—	—

Most-reported serious reactions: Skin ulcer, Subcutaneous emphysema, Immune thrombocytopenia, Cerebrovascular accident, Asthma.

Data from ClinicalTrials.gov NCT04523181 adverse events section.

Sponsor's own description

To evaluate the safety and efficacy of antroquinonol treatment of mild to moderate pneumonia due to COVID-19, as measured by the proportion of patients alive and free of respiratory failure.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Emerging small molecule antivirals may fit neatly into COVID-19 treatment.
   Fenton C, Keam SJ. · · 2022 · cited 14× · PMID 35250258 · DOI 10.1007/s40267-022-00897-8
2. Pharmacological strategies to prevent SARS-CoV-2 infection and treat the early phases of COVID-19.
   Scarabel L, Guardascione M, Dal Bo M, Toffoli G. · · 2021 · cited 12× · PMID 33476760 · DOI 10.1016/j.ijid.2021.01.035
3. Exploring the magic bullets to identify Achilles' heel in SARS-CoV-2: Delving deeper into the sea of possible therapeutic options in Covid-19 disease: An update.
   Thakur S, Thakur S, Mayank, Sarkar B, et al · · 2021 · cited 10× · PMID 33253764 · DOI 10.1016/j.fct.2020.111887