Covid19Phase 3NICLONEXNCT04558021
A Study To Evaluate The Efficacy And Safety Of a Novel Niclosamide Suspension Formulation For COVID-19
A Phase 3 study testing Niclosamide suspension in people with Covid19, run by Imuneks Farma ilac San. Tic. A.S. at 8 sites in Turkey (Türkiye).
Trial summary
This study aims to investigate the potential antiviral efficacy and safety of a novel formulation of Niclosamide; a well-known antihelmintic agent, together with an established COVID-19 treatment regimen in patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Niclosamide suspension
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 8 sitesTurkey (Türkiye)
- Study dates
- 8 Oct 2020to 14 Feb 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being able to understand the study and to give a written informed consent
- Adult hospitalized patients (aged ≥18) confirmed or suspected for COVID-19 according to the official General Information, Epidemiology and Diagnosis Guidance for COVID-19 (SARS-CoV-2 Infection) published by Republic of Turkey Ministry of Health showing at least one of the symptoms below:
- fever, cough, difficulty in breathing, sore throat, headache, muscle or body aches, new loss of taste or smell, diarreha without explanation of any cause than COVID-19 and history of herself/himself or her/his close contact presenting in the high-risk area of the disease within 14 days prior to the onset of symptoms or
- at least one of the symptoms of fever, cough, difficulty in breathing, sore throat, headache, muscle or body aches, new loss of taste or smell, diarrhea without explanation of any cause than COVID-19 and close contact with confirmed COVID-19 case within 14 days prior to symptoms or
- fever and at least one of the signs and symptoms of the severe acute respiratory infection (cough and difficulty in breathing) and need for hospitalization due to severe acute respiratory infection (SARI) explanation failure of the clinical features other than COVID-19 SARI: The need for hospitalization in a patient with acute respiratory infection due to fever, cough and dyspnea, tachypnea, hypoxemia, hypotension, wide radiological findings and consciousness developing in the last 14 days.
- or
- at least two of the signs and symptoms of fever, cough, difficulty in breathing, sore throat, headache, muscle or body aches, new loss of taste or smell, diarrhoea without explanation of any cause than COVID-19 or
- Patients detected with SARS-COV-2 by molecular methods who meet the criteria for possible case of SARS-COV-2
Who cannot join
- Who have allergy to niclosamide and/or any of the treatment agents and/or any of the excipients of the products,
- Who is diagnosed as "severe or critical case" (e.g. pneumonia or severe pneumonia),
- Whose National Early Warning Score 2 (NEWS2) score is indicated as "urgent" or "emergency",
- Any history of bone marrow transplant, solid-organ transplant, immune compromising conditions, immunomodulatory therapy, haematologic malignancy,
- Who have Multiple Sclerosis,
- Who have electrolyte imbalance, chronic haemodialysis or glomerular filtration rate < 30 30 mL/min/1.73m2,
Show all 16Show fewer
- Who have history of serious cardiovascular diseases,
- Who are diagnosed with another ongoing viral infection other than SARS CoV-2,
- Who have macrophage activation syndrome,
- Who have a need for coagulopathy treatment,
- Who have severe liver disease,
- Who is pregnant or nursing,
- Who are not suitable to 1st articles of inclusion criteria,
- Who is not eligible to swallow oral medications,
- Who use vitamin C as supplementary medication during the study,
- Who are included in another trial.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Turkey (Türkiye)8 sites, 8 recruiting
- Recruiting
Akdeniz Üniversitesi Tıp Fakültesi Hastanesi
Antalya, 07070
- Recruiting
Antalya Eğitim ve Araştırma Hastanesi
Antalya, 07100
- Recruiting
Gaziantep Üniversitesi Tıp Fakültesi Hastanesi
Gaziantep, 27410
Ayse O Mete, Dr., +90342 360 60 60, ayseozlem_ornek@hotmail.com
İlkay Karaoglan, Prof. Dr., +90342 360 60 60, ikaraoglan10@hotmail.com
- Recruiting
Gaziosmanpaşa Taksim Eğitim ve Araştırma Hastanesi
Istanbul, 34255
- Recruiting
Dokuz Eylül Üniversitesi Hastanesi
Izmir, 1606
- Recruiting
İzmir SBÜ Tepecik Eğitim ve Araştırma Hastanesi
Izmir, 35020
- Recruiting
SBÜ Dr. Suat Seren Göğüs Hastalıkları ve Cerrahisi Eğitim ve Araştırma Hastanesi
Izmir, 35110
- Recruiting
İzmir Katip Çelebi Üniversitesi Atatürk Eğitim ve Araştırma Hastanesi
Izmir, 35150
About this study
Official title: A Phase III, Randomized, Placebo-controlled, Clinical Trial to Evaluate the Efficacy and Safety of Co-administered Niclosamide in Patients Treated With an Established Regimen for Novel Coronavirus Infectious Disease (COVID-19)
This study aims to investigate the potential antiviral efficacy and safety of a novel formulation of Niclosamide; a well-known antihelmintic agent, together with an established COVID-19 treatment regimen in patients.
The aim of this study is to evaluate the safety and efficacy profile of niclosamide from the test product (Niclosamide 200 mg/10 mL Suspension) in patients treated for the novel coronavirus infectious disease (COVID-19) in a placebo controlled phase III trial. Both treatment groups will receive an established treatment regimen against COVID-19 together with either niclosamide or placebo.
The efficacy and safety of the molecule is well-known and the properties of novel formulation is well-established. The promising in vitro results of niclosamide as an antiviral compound is well documented and make it an ideal candidate as a therapy against SARS-CoV 2 infection. A good safety profile is expected with solid antiviral activity.
Read the detailed description
The study will be performed in accordance with the relevant articles of the Declaration of Helsinki (1964) as revised in Tokyo (1975), Venice (1983), Hong Kong (1989), Somerset West, RSA (1996), Edinburgh (2000), Washington (2002), Tokyo (2004) and Seoul (2008) and Fortaleza (2013).
The medications for the established treatment regimen will be supplied by Ministry of Health to the study sites. The other study medications, Investigational product and placebo, together with relative documentation, will be supplied to clinical sites by the sponsor. Niclosamide 200 mg/10 mL Suspension and placebo will be supplied together with certificates of analysis by the company responsible for manufacturing of the test product(s).The packaging and labelling of niclosamide and placebo will be done according to the GMP and GCP requirements.
All subjects will receive either 200 mg/10 mL niclosamide suspension or 10 mL placebo three times a day for 5 days, together with an established COVID-19 treatment regimen according to the official guidance for COVID-19 Adult Treatment Algorithm of Republic of Turkey Ministry of Health. Dosings will be administered in accordance with the treatment randomization table throughout the treatment duration.
On each drug administration, the identity of the subject will be confirmed by checking the Identity Card. Administration of the study medication will be performed by the investigator(s) and nurse(s) and supervised by a second medical professional to ensure the correctness of drug administration. Also, a monitor may attend during this procedure. The administration of the study medication is to be followed by a mouth check, to be documented in the CRF and certified by the Investigator.
The statistical analysis will be done according to the provisions of ICH Topic E9, Statistical Principles for Clinical Trials (CPMP/ICH/363/96), September 1998.
Statistical analysis will be performed as a valid case analysis including all subjects in which no major protocol deviations occurred and all primary target variables are available for measurement.
If a subject is to be excluded from evaluation, this decision has to be justified in the Final Study Report.
Continuous variables will be expressed as means ± standard deviations (SD) for the normally distributed data or median with interquartile (IQR) for the skewed data. Correspondingly, two-sample independent t-test and Mann-Whitney U test will be used to detect the difference between groups. Categorical variables will be described as number (%) and compared by χ² test or Fisher's exact test as appropriate. Kaplan-Meier method will be used to estimate the cumulative probability of the endpoint. Cox proportional hazards regression model will be conducted to determine the potential risk factors associated with the endpoint. Statistical significance will be defined as p<α=0.0054 for interim analysis, p<α=0.0492 for final analysis using O'Brien-Fleming alpha adjustment. All analyses will be done with R project.
The expected percentage of treatment success is 75% in the experimental group and 50% in the control group. The sample size calculation yields that 170 subjects are needed (85 for each group) to achieve 90% power at α=0.05. Considering potential dropouts, the sample size is estimated as 200 subjects (100 subjects for each group). For interim analysis, 100 subjects (50 subjects for each group) will be evaluated.
Before being enrolled to the clinical study, the subject(s) must consent to participate in the study by signing the informed consent form in response to a complete written and verbal explanation of the nature, scope and possible consequences of the clinical study explained in an understandable way for him/her by the physician.
Each subject will give in writing her/his authorization that the study data may be given for review to the responsible Local and National Authorities.
The subject information and informed consent form will be provided in duplicate [one signed version (original 1) will be left at the investigator; the other signed version (original 2) will be forwarded to the subject].
- Conditions
- Covid19
- Being tested
- Niclosamide suspension, Placebo
- Keywords
- Coronavirus, Niclosamide Suspension, Anti-viral
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niclosamide suspensionDrug
Also called Niclonex
200mg/10ml
PlaceboOther
10ml placebo(absent of niclosamide)
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm-I | Experimental | Niclosamide 200 mg/10 mL Suspension will be administered to patients 3 times a day for 5 days along with the treatment regimen selected according to the official guidance for COVID-19 Adult Treatment Algorithm established by Republic of Turkey Ministry of Health Receives: Drug: Niclosamide suspension |
| Intervention Arm-II | Placebo comparator | 10 mL placebo will be administered to patients 3 times a day for 5 days along with the treatment regimen selected according to the official guidance for COVID-19 Adult Treatment Algorithm established by Republic of Turkey Ministry of Health Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician's judgment on clinical recovery from the time of admission
The physician will check for the following symptoms:
- Fever: axillary temperature ≤36.6°C or oral temperature ≤37.2 °C;
- Respiratory rate: ≤24/minute on room air;
- Oxygen saturation: >94% on room air;
- Cough: mild or absent on a patient reported scale of severe, moderate, mild, absent.)
Measured: Day 1 to day 19
Secondary outcomes (5)
Clinical improvement in NEWS2
(National Early Warning Score 2) to 0 to 3 (Improvement in fever, respiratory rate, oxygen saturation,alleviation of cough scores to 3 points to 0 in 72 hours)
Measured: 3 days from admission
Improvement in serum biomarkers
An elevated D-dimer,ferritin, thrombocyte, PT, aPTT, troponine and fibrinogen were associated with a poor outcome in COVID19. These parameters will be checked on day 1 and day 3.
Measured: Day 1 to day 3
Requirement for indotracheal intubation
Requirement for indotracheal intubation is a key outcome for unsuccesful treatment
Measured: Day 1 to day 19
Occurrence of Macrophage Activation Syndrome(MAS)
Occurrence of Macrophage Activation Syndrome(MAS) will alert the physician that the patients condition is worsening.
Measured: Day 1 to day 19
Occurrence of Coagulopathy
Occurrence of Coagulopathy will alert the physician that the patients condition is worsening.
Measured: Day 1 to day 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start8 Oct 2020
- Primary completion30 Jan 2021 (estimated)
- Study completion14 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 200 patients will receive either 200 mg niclosamide in 10 mL of suspension or 10 mL of placebo three times a day together with an established treatment regimen in 1:1 ratio. The study will be conducted in 2 parts: an interim analysis will be conducted after the first 100 patients.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imuneks Farma ilac San. Tic. A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aydin Erenmemisoglu, Prof.Dr., Study director, ALPAN Farma Ltd.Sti.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558021
- Sponsor's protocol ID
- NOV2020/01930
- Acronym
- NICLONEX
- Status last verified
- Oct 2020
- First submitted
- 18 Sep 2020
- Last updated
- 12 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu CJ, Jan JT, Chen CM, Hsieh HP, Hwang DR, Liu HW, Liu CY, Huang HW, Chen SC, Hong CF, Lin RK, Chao YS, Hsu JT. Inhibition of severe acute respiratory syndrome coronavirus replication by niclosamide. Antimicrob Agents Chemother. 2004 Jul;48(7):2693-6. doi: 10.1128/AAC.48.7.2693-2696.2004.
PubMed 15215127
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Placebo-controlled, Clinical Trial to Evaluate the Efficacy and Safety of Co-administered Niclosamide in Patients Treated With an Established Regimen for Novel Coronavirus Infectious Disease (COVID-19)
- ClinicalTrials.gov ID
- NCT04558021
- Acronym / sponsor ID
- NICLONEX / NOV2020/01930
- Conditions
- Covid19
- Keywords
- Coronavirus, Niclosamide Suspension, Anti-viral
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Imuneks Farma ilac San. Tic. A.S.Industry (pharma, biotech, devices)
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 30 Jan 2021 (estimated)
- Study completion
- 14 Feb 2021 (estimated)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the potential antiviral efficacy and safety of a novel formulation of Niclosamide; a well-known antihelmintic agent, together with an established COVID-19 treatment regimen in patients.
The aim of this study is to evaluate the safety and efficacy profile of niclosamide from the test product (Niclosamide 200 mg/10 mL Suspension) in patients treated for the novel coronavirus infectious disease (COVID-19) in a placebo controlled phase III trial. Both treatment groups will receive an established treatment regimen against COVID-19 together with either niclosamide or placebo.
The efficacy and safety of the molecule is well-known and the properties of novel formulation is well-established. The promising in vitro results of niclosamide as an antiviral compound is well documented and make it an ideal candidate as a therapy against SARS-CoV 2 infection. A good safety profile is expected with solid antiviral activity.
Detailed description
The study will be performed in accordance with the relevant articles of the Declaration of Helsinki (1964) as revised in Tokyo (1975), Venice (1983), Hong Kong (1989), Somerset West, RSA (1996), Edinburgh (2000), Washington (2002), Tokyo (2004) and Seoul (2008) and Fortaleza (2013).
The medications for the established treatment regimen will be supplied by Ministry of Health to the study sites. The other study medications, Investigational product and placebo, together with relative documentation, will be supplied to clinical sites by the sponsor. Niclosamide 200 mg/10 mL Suspension and placebo will be supplied together with certificates of analysis by the company responsible for manufacturing of the test product(s).The packaging and labelling of niclosamide and placebo will be done according to the GMP and GCP requirements.
All subjects will receive either 200 mg/10 mL niclosamide suspension or 10 mL placebo three times a day for 5 days, together with an established COVID-19 treatment regimen according to the official guidance for COVID-19 Adult Treatment Algorithm of Republic of Turkey Ministry of Health. Dosings will be administered in accordance with the treatment randomization table throughout the treatment duration.
On each drug administration, the identity of the subject will be confirmed by checking the Identity Card. Administration of the study medication will be performed by the investigator(s) and nurse(s) and supervised by a second medical professional to ensure the correctness of drug administration. Also, a monitor may attend during this procedure. The administration of the study medication is to be followed by a mouth check, to be documented in the CRF and certified by the Investigator.
The statistical analysis will be done according to the provisions of ICH Topic E9, Statistical Principles for Clinical Trials (CPMP/ICH/363/96), September 1998.
Statistical analysis will be performed as a valid case analysis including all subjects in which no major protocol deviations occurred and all primary target variables are available for measurement.
If a subject is to be excluded from evaluation, this decision has to be justified in the Final Study Report.
Continuous variables will be expressed as means ± standard deviations (SD) for the normally distributed data or median with interquartile (IQR) for the skewed data. Correspondingly, two-sample independent t-test and Mann-Whitney U test will be used to detect the difference between groups. Categorical variables will be described as number (%) and compared by χ² test or Fisher's exact test as appropriate. Kaplan-Meier method will be used to estimate the cumulative probability of the endpoint. Cox proportional hazards regression model will be conducted to determine the potential risk factors associated with the endpoint. Statistical significance will be defined as p<α=0.0054 for interim analysis, p<α=0.0492 for final analysis using O'Brien-Fleming alpha adjustment. All analyses will be done with R project.
The expected percentage of treatment success is 75% in the experimental group and 50% in the control group. The sample size calculation yields that 170 subjects are needed (85 for each group) to achieve 90% power at α=0.05. Considering potential dropouts, the sample size is estimated as 200 subjects (100 subjects for each group). For interim analysis, 100 subjects (50 subjects for each group) will be evaluated.
Before being enrolled to the clinical study, the subject(s) must consent to participate in the study by signing the informed consent form in response to a complete written and verbal explanation of the nature, scope and possible consequences of the clinical study explained in an understandable way for him/her by the physician.
Each subject will give in writing her/his authorization that the study data may be given for review to the responsible Local and National Authorities.
The subject information and informed consent form will be provided in duplicate [one signed version (original 1) will be left at the investigator; the other signed version (original 2) will be forwarded to the subject].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 200 patients will receive either 200 mg niclosamide in 10 mL of suspension or 10 mL of placebo three times a day together with an established treatment regimen in 1:1 ratio. The study will be conducted in 2 parts: an interim analysis will be conducted after the first 100 patients.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm-I | Experimental | Drug: Niclosamide suspensionNiclosamide 200 mg/10 mL Suspension will be administered to patients 3 times a day for 5 days along with the treatment regimen selected according to the official guidance for COVID-19 Adult Treatment Algorithm established by Republic of Turkey Ministry of Health |
| Intervention Arm-II | Placebo comparator | Other: Placebo10 mL placebo will be administered to patients 3 times a day for 5 days along with the treatment regimen selected according to the official guidance for COVID-19 Adult Treatment Algorithm established by Republic of Turkey Ministry of Health |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Being able to understand the study and to give a written informed consent
- Adult hospitalized patients (aged ≥18) confirmed or suspected for COVID-19 according to the official General Information, Epidemiology and Diagnosis Guidance for COVID-19 (SARS-CoV-2 Infection) published by Republic of Turkey Ministry of Health showing at least one of the symptoms below:
- or
- Patients detected with SARS-COV-2 by molecular methods who meet the criteria for possible case of SARS-COV-2
Key exclusion criteria (16 listed)
- Who have allergy to niclosamide and/or any of the treatment agents and/or any of the excipients of the products,
- Who is diagnosed as "severe or critical case" (e.g. pneumonia or severe pneumonia),
- Whose National Early Warning Score 2 (NEWS2) score is indicated as "urgent" or "emergency",
- Any history of bone marrow transplant, solid-organ transplant, immune compromising conditions, immunomodulatory therapy, haematologic malignancy,
- Who have Multiple Sclerosis,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Niclosamide suspensionAlso: Niclonex200mg/10ml | Drug | Intervention Arm-I |
| Placebo10ml placebo(absent of niclosamide) | Other | Intervention Arm-II |
Primary outcome
Physician's judgment on clinical recovery from the time of admission
Time frame: Day 1 to day 19
The physician will check for the following symptoms: * Fever: axillary temperature ≤36.6°C or oral temperature ≤37.2 °C; * Respiratory rate: ≤24/minute on room air; * Oxygen saturation: >94% on room air; * Cough: mild or absent on a patient reported scale of severe, moderate, mild, absent.)
5 secondary outcomes
Clinical improvement in NEWS2
Time frame: 3 days from admission
Improvement in serum biomarkers
Time frame: Day 1 to day 3
Requirement for indotracheal intubation
Time frame: Day 1 to day 19
Occurrence of Macrophage Activation Syndrome(MAS)
Time frame: Day 1 to day 19
Occurrence of Coagulopathy
Time frame: Day 1 to day 19
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- Background: PubMed 15215127Wu CJ, Jan JT, Chen CM, Hsieh HP, Hwang DR, Liu HW, Liu CY, Huang HW, Chen SC, Hong CF, Lin RK, Chao YS, Hsu JT. Inhibition of severe acute respiratory syndrome coronavirus replication by niclosamide. Antimicrob Agents Chemother. 2004 Jul;48(7):2693-6. doi: 10.1128/AAC.48.7.2693-2696.2004.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aydin Erenmemisoglu, Prof.Dr. study director
ALPAN Farma Ltd.Sti.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Niclosamide suspension in people with Covid19, run by Imuneks Farma ilac San. Tic. A.S. at 8 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aydin Erenmemisoglu, Prof.Dr. (+90 352 224-2322, erenmemis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician's judgment on clinical recovery from the time of admission (time frame: Day 1 to day 19). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04558021, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2020.