Amantadine for COVID-19 (ACT)
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|ClinicalTrials.gov Identifier: NCT04894617|
Recruitment Status : Not yet recruiting
First Posted : May 20, 2021
Last Update Posted : May 25, 2021
Corona virus disease 19 (COVID-19) is a devastating pandemic. By early February 2021, more than 102 million people were infected globally with more than 2.2 million reported deaths. Current treatments are approved for hospitalized patients with severe COVID-19 only. No treatment is approved to prevent progression to severe COVID-19 in the early stages of disease. Previous studies have indicated that amantadine is effective against severe acute respiratory syndrome corona virus 1 (SARS-CoV-1). Trials are needed to determine if this translates to a beneficial effect in patients with COVID-19. We hypothesize that preemptive therapy with amantadine of non-hospitalized high-risk adults with SARS-CoV-2 infection disease will prevent disease progression and hospitalization.
Methods and analysis:
The study is a randomized, double-blinded, placebo-controlled, single center study with two treatment arms; oral amantadine or placebo. Individuals with confirmed SARS-CoV-2 infection and one of following; i) age ≥ 50 years or ii) ≥ 18 years of age with at least one comorbidity or iii) ≥ 18 years of age with a body mass index (BMI) above 30 will be enrolled in the study. We plan to enroll 113 persons in each arm, with a total of 226 participants. Follow up period is 90 days. The primary outcome is disease severity on day 14 assessed by the 8-point COVID outcome scale proposed by the world health organization.
Ethics and dissemination:
Approvals by the Ethics Committee and National Competent Authorities will be obtained prior to study initiation. Results will be submitted for publication in a peer-reviewed journal and presented at international conferences.
The results of the study will contribute with important knowledge on the efficacy and safety of oral amantadine in the treatment of non-hospitalized high-risk individuals with SARS-CoV-2 infection.
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Drug: Amantadine Drug: Lactose monohydrate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||226 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, double-blinded, placebo-controlled study|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
Unblinded personnel will perform randomization into one of two arms (ratio 1:1). The randomization list will be generated centrally in random blocks. Blinded personnel will not have access to the randomization key. Unblinded staff will deliver sealed envelopes containing treatment allocation to blinded study personnel to use for emergency unblinding.
All investigators, outcome assessors, and study participants will be blinded to the treatment allocation.
|Official Title:||Amantadine for COVID-19: A Randomized, Placebo Controlled, Double-blinded, Clinical Trial|
|Estimated Study Start Date :||May 2021|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||April 2022|
Active Comparator: Amantadine
The intervention group will receive a dose at day 1 of amantadine 100 mg followed by 100 mg amantadine after 6 hours. The following 4 consecutive days, study participants will receive a daily dose of 200mg amantadine, 100 mg (1 capsule) morning and 100 mg (1 capsule) evening, yielding 5 days of treatment in total (10 capsules in total).
200 mg Amantadine daily for a total of 5 days.
Placebo Comparator: Placebo
The control group will receive placebo treatment with lactose monohydrate; 1 capsule, followed by 1 capsule after 6 hours on day 1. The following 4 consecutive days, study participants will receive 1 capsule morning and 1 capsule evening, yielding 5 days of treatment in total (10 capsules in total).
Drug: Lactose monohydrate
Lactose monohydrate two tablet daily for a total of 5 days.
- Clinical status on day 14 [ Time Frame: 14 days ]
Clinical status on day 14 according to 8 point ordinal scale for clinical improvement.
No limitations to activities=1, Limitations to activities=2, Hospitalized no oxygen therapy=3, Oxygen by mask or nasal prongs=4, Non-invasive ventilation or high flow oxygen=5, Intubation and mechanical ventilation=6, Ventilation + additional organ support, ECMO=7, Death=8.
- Mortality [ Time Frame: Day 7, 14, 28 and 90 ]Mortality rate
- Mechanical ventilation [ Time Frame: Day 7, 14, 28 and 90 ]Incidence of Mechanical ventilation
- Hospitalization [ Time Frame: Day 7, 14, 28 and 90 ]Incidence of hospitalization
- Duration of hospitalization [ Time Frame: 90 days ]Duration of hospitalization
- PCR SARS-CoV-2 [ Time Frame: Day 7 ]Proportion with negative SARS-CoV-2 oropharyngeal swap
- Adverse events [ Time Frame: 90 days ]Frequency of adverse events
- Severe adverse events [ Time Frame: 90 days ]Frequency of severe adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04894617
|Contact: Mette M Rosenkilde, PhDemail@example.com|
|Principal Investigator:||Nina M Weis, PhD||Copenhagen University Hospital, Hvidovre|