Chloroquine, Hydroxychloroquine or Only Supportive Care in Patients AdmItted With Moderate to Severe COVID-19 (ARCHAIC)
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|ClinicalTrials.gov Identifier: NCT04362332|
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Rationale: Currently there are no approved treatments for COVID-19. In the Dutch treatment protocol guideline (SWAB) designated treatment is supportive care with the option to add chloroquine base (CQ) or hydroxychloroquine (HCQ). CQ and HCQ are implemented because of their in vitro activity, results from small animal studies, and anecdotal patient's data. There are no published randomized studies with these medications in patients with disease caused by any coronavirus.
Objective: To evaluate if treatment with only supportive care or addition of one of two anti-COVID_19 agents (chloroquine or hydroxychloroquine) results in less disease progression in patients with moderate to severe COVID-19 who require hospital admission.
Study design: Multicentre, cluster randomized cross-over, open label trial. Hospitals will be randomly allocated to one of 3 treatment arms in sequential periods of one week: chloroquine base versus hydroxychloroquine versus supportive care without any drug presumed active against SARS-COV-2. Patients will be treated based on the date of inclusion.
Study population: Adults aged of 18 years and older with moderate to severe, with a NEWS-2 score ≤ 5, laboratory confirmed COVID-19, who require hospital admission in a ward outside the Medium Care or Intensive Care.
Intervention (if applicable): Depending on the treatment arm, the study subject will receive only supportive care or an addition with one of the two agents active against SARS-CoV-2 (chloroquine or hydroxychloroquine).
Main study parameters/endpoints: Disease progression defined as a NEWS-2 score ≥ 7 within 14 days, or admission to Medium Care or Intensive Care Unit, or death.
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Chloroquine Sulfate Drug: Hydroxychloroquine Other: Standard supportive care||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||950 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
|Masking:||None (Open Label)|
|Masking Description:||cluster randomized design|
|Official Title:||An Open Label Cluster Randomized Controlled Trial of Chloroquine, Hydroxychloroquine or Only Supportive Care in Patients AdmItted With Moderate to Severe COVID-19|
|Actual Study Start Date :||April 14, 2020|
|Estimated Primary Completion Date :||April 14, 2021|
|Estimated Study Completion Date :||May 14, 2021|
Active Comparator: chloroquine
1. Supportive care + chloroquine base arm: loading dose 600mg, followed by 300mg 12 hours later, followed by 300mg bid for 4 days; total treatment duration of 5 days
Drug: Chloroquine Sulfate
Other: Standard supportive care
Active Comparator: hydroxychloroquine
2. Supportive care + hydroxychloroquine arm: loading dose 400mg bid, followed by 200mg bid for 4 days; total treatment duration of 5 days.
Other: Standard supportive care
No Intervention: Supportive care only
3. Supportive care only.
- Composite endpoint with disease progression defined as a NEWS2score ≥ 7 within 14 days or resulting in admission to Intensive/Medium Care unit or resulting in death within 14 days. [ Time Frame: 14 days ]Composite endpoint with disease progression defined as a NEWS2score ≥ 7 within 14 days or resulting in admission to Intensive/Medium Care unit or resulting in death within 14 days.
- Side effects [ Time Frame: 28 days ]Secondary study parameters/endpoints Side effects of different drugs leading to regimen change or discontinuation of the antiviral treatment
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): NCT04362332