Effectiveness and Safety of Quinine Sulfate as add-on Therapy for COVID-19 in Hospitalized Adults in Indonesia ( DEAL-COVID19 )

NCT05808231 | Unknown DMC

• 1 other identifier: Pharm-202005.12
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

This is a multicenter, randomized, open-label, controlled trial to evaluate the effectiveness and safety of Quinine Sulfate as an add-on therapy in hospitalized adults with COVID-19. The study is a multi-center trial that will be conducted in up to approximately 2 sites nationally. New sites may be added as needed after appropriate assessment. Interim monitoring will be conducted to evaluate the arms and for safety and effectiveness. Any changes would be accompanied by an updated sample size. Subjects will be assessed while hospitalized. All subjects will undergo a series of laboratory tests (CBC, SGOT, SGPT, Ureum, Creatinine, EKG, and PCR), clinical examination (clinical assessment, vital signs, accompanying drugs, and other medical conditions) and safety assessment (serious adverse events/ SAE) Randomization will be performed 1:1 for each arm. Arm 1 = Standard of Care (SoC) alone, arm 2 = SoC + Quinine Sulfate

Conditions

COVID-19

Keywords

COVID-19; Quinine Sulfate

Outcome Measures

Primary Outcomes (1)

• The clinical condition of the subjects assessed on a 7-point ordinal scale

  The clinical condition of the subjects was assessed until day 10 using a 7-point ordinal scale, as follows: 1. Death 2. Hospitalization, with invasive mechanical ventilation or ECMO 3. Hospitalization, with non-invasive ventilation or high-flow oxygen device; 4. Hospitalized, requires additional oxygen; 5. Hospitalized, does not require additional oxygen; 6. Not hospitalized, activity restrictions; 7. No hospitalization, no activity restrictions

  From the date of randomization until the date of first documented subject discharge or death from any cause, assessed up to 10 days

Secondary Outcomes (3)

• Duration of oxygenation

  From the date of randomization until the date of first documented subject discharge or death from anycause, assessed up to 10 days

• Duration of ventilation

  From the date of randomization until the date of first documented subject discharge or death from anycause, assessed up to 10 days

• Length of stay

  From the date of randomization until the date of first documented subject discharge or death from anycause, assessed up to 10 days

Other Outcomes (3)

• Safety Outcome (Change in CBC, SGOT, SGPT, Ureum and Creatinine)

  Will be examined at days 0 (before treatment) and at the end of treatment

• Safety Outcome (Number of reported Serious Adverse Event)

  From the date of randomization until the date of first documented subject discharge or death from anycause, assessed up to 10 days

• Safety Outcome (Change in QT interval based on ECG result)

  Will be examined at days 0, 3, 6, 9 after starting treatment

Study Arms (2)

Control Group

OTHER

Standard of Care alone

Drug: Standard of Care

Experimental Group

OTHER

Standard of Care + Quinine Sulfate

Drug: Standard of Care + Quinine Sulfate

Interventions

Standard of Care + Quinine Sulfate DRUG

Standard of Care + Quinine Sulfate

Experimental Group

Standard of Care DRUG

Standard of Care for COVID-19 mild and moderate symptom

Control Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female patients aged ≥ 18 years to 50 years old who are hospitalized with Covid-19 based on clinical symptoms determined by physician and confirmed by Rapid Test or PCR test with mild to moderate symptoms
• Female subjects of child-bearing age agree to take effective contraceptive measures during the study until seven days of the last oral medication
• Willing to receive a random assignment to any designated treatment group and not participating in another study at the same time
• Not participating in other research at the same time.
• Subjects agreed to participate in the study and signed an information sheet and informed consent.

You may not qualify if:

• Received quinine sulfate, hydroxychloroquine, chloroquine, lumefantrine, or mefloquine within 30 days prior to this research;
• Having receive any treatment for COVID-19 prior to this research;
• Any contraindication to quinine sulfate
• Inability to swallow pills or any other reason that compliance with the medical regimen is not likely;
• Pregnant and breastfeeding;
• Severe underlying disease where treatment and follow up is not likely to be beneficial to the patient based on physician judgement (e.g. retinopathy, cardiovascular disease (QTc \> 500 mdet (narrow QRS); QTc ≥ 550 mdet (wide QRS)), heart arrythmia, uncontrolled diabetes mellitus, hypertension, chronic pulmonary disease, asthma, chronic kidney disease (Creatinine \> 2x normal value), liver disease (SGOT/SGPT \> 2x normal value), chronic neurological disease, or etc.). This includes people requiring care in designated supported living facilities and severe dementia;
• Platelet count less than 150,000 and more than 450,000 cells/μL;
• Possibility of being transferred to a non-study-hospital within 72 hours.

Sponsors & Collaborators

• Universitas Padjadjaran: lead
• National Research and Innovation Agency of Indonesia: collaborator
• Prodia Diacro Laboratories P.T.: collaborator

Study Sites (2)

Gatot Soebroto Army Central Hospital (RSPAD)

Jakarta, DKI Jakarta, 10410, Indonesia

RECRUITING

Dr. Hasan Sadikin Central General Hospital (RSHS)

Bandung, West Java, 40161, Indonesia

RECRUITING

Related Publications (26)

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Related Links

• Infeksi Emerging: Media Informasi Resmi Terkini Penyakit Infeksi Emerging.
• WHO Director-General's opening remarks at the media briefing on COVID-19
• Letter of Recommendation for the Use of Hydroxychloroquine/Chloroquine Phosphate in the Treatment of COVID-19 dated 04 June 2020.
• National Library of Medicine
• FDA Drug Safety Communication: New risk management plan and patient Medication Guide for Qualaquin (quinine sulfate)

MeSH Terms

Conditions

COVID-19

Interventions

Standard of Care; Quinine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Cinchona Alkaloids; Alkaloids; Heterocyclic Compounds; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Keri Lestari

CONTACT

+62811216942; lestarikd@unpad.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Keri Lestari, M.Si, S.Si, Apt.

Model Details: Participants will be randomised to be in Arm 1 or Arm 2 using pre-defined randomisation list; 1:1 for each arm. Arm 1 receives Standard of Care Arm 2 receives Standard of Care+Quinine Sulfate

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: April 11, 2023
• Study Start: April 26, 2021
• Primary Completion: June 30, 2022
• Study Completion: May 31, 2023
• Last Updated: April 11, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (2)