COVID-19 Clinical Trial
— ARCHAICOfficial title:
An Open Label Cluster Randomized Controlled Trial of Chloroquine, Hydroxychloroquine or Only Supportive Care in Patients AdmItted With Moderate to Severe COVID-19
Verified date | June 2020 |
Source | UMC Utrecht |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 25 |
Est. completion date | June 8, 2020 |
Est. primary completion date | June 8, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 110 Years |
Eligibility |
Inclusion Criteria: - - Patients (=18 years of age) admitted to the hospital with confirmed COVID-19 and not needing admission to MC or ICU - Patient has moderate to severe COVID-19. This will be defined as patients with NEWS-2 score = 5. - Willing and able to give written informed consent Exclusion Criteria: - - Severe Covid-19 defined as NEWS-2 score >5 or admission to the ICU needing ventilation or pressure support. - Contra-indications for hydroxychloroquine or chloroquine - Unable to take oral medication (chloroquine and hydroxychloroquine can be administered through tube feeding which is considered oral administration) - Identified allergies to 4-aminoquinoline - Severe diseases of the blood system - 6-phosphate dehydrogenase deficiency - History of acute myocardial infarction, unstable angina pectoris, severe arrhythmia (frequent ventricular, ventricular tachycardia, ventricular fibrillation) in recent 6 months; New York Heart Association (NYHA) level III-IV - Known corrected QT interval (QTc) = 500ms. - Uncorrected severe hypokalaemia (< 2,5 mmol/l) or uncorrected severe hypomagnesemia (< 0.6 mmol/l) - Pancreatitis - Refusal to participate expressed by patient or legally authorized representative if they are present |
Country | Name | City | State |
---|---|---|---|
Netherlands | UMCU | Utrecht |
Lead Sponsor | Collaborator |
---|---|
UMC Utrecht | ZonMw: The Netherlands Organisation for Health Research and Development |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 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. | 14 days | |
Secondary | Side effects | Secondary study parameters/endpoints Side effects of different drugs leading to regimen change or discontinuation of the antiviral treatment | 28 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT06065033 -
Exercise Interventions in Post-acute Sequelae of Covid-19
|
N/A | |
Completed |
NCT06267534 -
Mindfulness-based Mobile Applications Program
|
N/A | |
Completed |
NCT05047601 -
A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection
|
Phase 2/Phase 3 | |
Recruiting |
NCT05323760 -
Functional Capacity in Patients Post Mild COVID-19
|
N/A | |
Recruiting |
NCT04481633 -
Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection
|
N/A | |
Completed |
NCT04612972 -
Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru
|
Phase 3 | |
Completed |
NCT04537949 -
A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults
|
Phase 1/Phase 2 | |
Recruiting |
NCT05494424 -
Cognitive Rehabilitation in Post-COVID-19 Condition
|
N/A | |
Active, not recruiting |
NCT06039449 -
A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2
|
Phase 3 | |
Enrolling by invitation |
NCT05589376 -
You and Me Healthy
|
||
Completed |
NCT05158816 -
Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
|
||
Recruiting |
NCT04341506 -
Non-contact ECG Sensor System for COVID19
|
||
Completed |
NCT04384445 -
Zofin (Organicell Flow) for Patients With COVID-19
|
Phase 1/Phase 2 | |
Completed |
NCT04512079 -
FREEDOM COVID-19 Anticoagulation Strategy
|
Phase 4 | |
Completed |
NCT05975060 -
A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT05542862 -
Booster Study of SpikoGen COVID-19 Vaccine
|
Phase 3 | |
Withdrawn |
NCT05621967 -
Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation
|
N/A | |
Terminated |
NCT05487040 -
A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
|
Phase 1 | |
Terminated |
NCT04498273 -
COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
|
Phase 3 | |
Active, not recruiting |
NCT06033560 -
The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure
|