PneumoniaPhase 1NCT03690583
Immunomodulation by Zinc Supplementation in Children With Pneumonia
A Phase 1 study testing Zinc sulfate and Glucose in people with Pneumonia and Children, Only, run by Universidad Nacional Autonoma de Mexico at 2 sites in Mexico.
Trial summary
Pneumonia is one of the main causes of morbidity and mortality in the world, especially in developing countries like ours. The National Health and Nutrition Survey of Mexico, in 2006 showed underweight in 472,890 (5%) children under five years, low height in 1,194,805 (12.7%) and wasting in153,000 (1.6%) children. Read more about this study
- Who is it for?
- Ages 1 month to 5 years
- Conditions the study is for
- Pneumonia, Children, Only
- What is being tested?
- Zinc sulfate and Glucose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 2 sitesMexico
- Study dates
- 29 Jan 2014to 23 Feb 2016
- Phase
- Phase 1
- 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 1 month to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 1 month to 5 years old with clinical and/or radiological diagnosis of pneumonia
- Admitted to the Emergency room at the participant institutions
Who cannot join
- Prematurity
- Cardiopathy
- Pneumopathy
- Immunosuppression (congenital, chemotherapy or other cause)
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites
Hospital General de Mexico
México, 06726
Hospital Pediatrico de Coyoacan
Mexico City, Mexico City, 04500
About this study
Official title: Assessment of the Immunomodulatory Effect of Zinc Supplementation on the Clinical Evolution of Children With Pneumonia
Pneumonia is one of the main causes of morbidity and mortality in the world, especially in developing countries like ours.
The National Health and Nutrition Survey of Mexico, in 2006 showed underweight in 472,890 (5%) children under five years, low height in 1,194,805 (12.7%) and wasting in153,000 (1.6%) children. Zinc is decreased in malnutrition and is an essential cofactor for many proteins involved in cellular processes. Zinc deficiency leads to a decrease in the number of T cells, the ratio of Th1 to Th2 cells and the production of Th1 cytokines such as interferon gamma, with alteration in T cell mediated immunity. In malnourished children zinc supplementation restores the immune response. Reports of zinc supplementation in children with pneumonia are controversial.
Read more
The aims of this study are to evaluate the immunomodulatory effect of zinc supplementation in the clinical course of children with pneumonia, to evaluate the lymphoproliferative and cytokine response in these children and to explore whether the viral or bacterial etiology is related to the clinical response to supplementation with this micronutrient.
A clinical, randomized, prospective, controlled, double blinded study will be carried out. Children from 1 month to 5 years of age will be included, with the clinical and / or radiological diagnosis of pneumonia that enter the emergency room of the participant institutions. Empirical treatment for pneumonia will begin and each patient will be randomized 1:1 in 2 groups. One will receive zinc supplementation and another a placebo (glucose). Samples will be taken to determine the etiology (nasal lavage for multiplex polymerase chain reaction for 16 respiratory viruses and 6 bacteria) and a blood sample to measure the cytokine pattern and the lymphoproliferative response. After 7 days of treatment, a second sample will be taken for immunological studies (cytokine pattern and lymphoproliferative response). The following parameters will be measured to evaluate the clinical evolution: respiratory rate, temperature, oxygen saturation, inability to eat, duration of cough, rales, temperature normalization time, normalization time of oxygen saturation, normalization time of the respiratory rate, hospitalization time and outcome (discharge due to clinical improvement or death). A correlation will be made between the improvement in clinical parameters and mortality in the zinc supplementation group and the probable bacterial or viral etiology.
Read the detailed description
Background: Pneumonia is one of the main causes of morbidity and mortality in the world, especially in developing countries like ours. Of an estimated 8.795 million deaths in children under 5 in the world in 2008, 68% were infectious causes, with the highest percentage due to pneumonia in 18%, followed by diarrhea in 15% and malaria in 8%, 41% of the deaths were in neonates, pneumonia being the 4th cause of death in this age group. Acute respiratory infections, diarrhea and malnutrition together cause 10% of deaths among children under 1 year of age. In Mexico, a pneumonia mortality rate of 120 per 100,000 inhabitants is reported in children under 1 year of age, and 5 deaths per 100,000 inhabitants in children from 1 to 4 years of age in 2007.
The results of the National Health and Nutrition Survey (ENSANUT), carried out in 2006 by the National Institute of Public Health, showed that 472,890 children under five years of age were classified as underweight (5%), 1,194,805 with low height (12.7%) and around 153,000 children with wasting (1.6%). The overall prevalence of anemia in urban areas was 22.8%, while in rural areas was 26.1%. Likewise, it is known that there are specific deficiencies of some micronutrients, such as vitamin A, C, E, zinc, iron, folic acid and iodine, among others. Malnourished children loose between 12 and 15% of their intellectual potential, have a higher risk of infectious diseases 8 to 12 times more than a healthy child and are more prone to chronic degenerative diseases. Malnutrition causes among others an effect of immunosuppression. One of the micronutrients that is decreased in malnutrition is zinc. Zinc is an essential cofactor for many proteins involved in cellular processes such as differentiation, proliferation and apoptosis. During zinc deficiency, the development of T lymphocytes, the polarization in effector cells and their function are altered. This leads to a decrease in the number of T cells, a decrease in the ratio of Th1 to Th2 cells with a decrease in the production of Th1 cytokines such as interferon gamma, and alteration in the defense mediated by T cells. In malnourished children zinc supplementation restores the immune response. Reports of zinc supplementation in children with infectious diseases are controversial. A study in Uganda reports that supplementation with zinc in children from 6 months to 5 years of age with severe pneumonia decreased the mortality from 12% to 4%, with a relative risk reduction of 0.67. Cellular immunity plays a very important role in the defense of the host against viruses and bacteria, zinc supplementation in children who have some degree of malnutrition and who suffer a serious infection could improve the immune response and improve the ability to respond to acute infection.
The aim of this study is to evaluate the immunomodulatory effect of zinc supplementation in the clinical course of children with pneumonia, to evaluate the lymphoproliferative and cytokine response in these children and to explore whether the viral or bacterial etiology is related to the clinical response to supplementation with this micronutrient.
Methods: This is a clinical, randomized, prospective, controlled, double blinded study. Children from 1 month to 5 years of age will be included, with the clinical and / or radiological diagnosis of pneumonia that enter the emergency room of the participant institutions. Empirical treatment for pneumonia will begin and each patient will be randomized 1:1 in 2 groups. One will receive zinc supplementation (10 mg of zinc sulfate in children younger than 1 year old and 20 mg of zinc sulfate in children older than 1 year old) and another a placebo (glucose 10 mg). Samples will be taken to determine the etiology (pharyngeal exudate, nasal lavage for multiplex polymerase chain reaction for 16 respiratory viruses and 6 bacteria) and a blood sample to measure the cytokine pattern and the lymphoproliferative response. After 7 days of treatment, a second sample will be taken for immunological studies (cytokine pattern and lymphoproliferative response). The following parameters will be measured to evaluate the clinical evolution: respiratory rate, temperature, oxygen saturation, inability to eat, duration of cough, crackling, temperature normalization time, normalization time of oxygen saturation, normalization time of the respiratory rate, hospitalization time and outcome (discharge due to clinical improvement or death). A correlation will be made between the improvement in clinical parameters and mortality in the zinc supplementation group and the probable bacterial or viral etiology.
- Conditions
- Pneumonia, Children, Only
- Being tested
- Zinc sulfate, Glucose
- Keywords
- Pneumonia, Zinc supplementation, Cytokines, Lymphoproliferation, Viruses, Respiratory bacteria
- Medical subject headings
- Pneumonia, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc sulfateDrug
Also called Zinc
Zinc sulfate 10 mg for children younger than 1 year old, 20 mg for children older than 1 year old, will be diluted in 1 ml of sterile water and administered orally every day in the morning during hospitalization
GlucoseOther
The placebo group will receive glucose diluted in 1 ml of sterile water orally every day during hospitalization
| Study group | Role | What they receive |
|---|---|---|
| Zinc group | Experimental | Zinc sulfate 10 mg in children younger than 1 year old, 20 mg in children older than 1 year old Receives: Drug: Zinc sulfate |
| Placebo group | Placebo comparator | Glucose Receives: Other: Glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of improvement of respiratory distress
Hours since the admission to the hospital to disappear the respiratory distress
Measured: From date of randomization util the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 days
Time of improvement of oxygen desaturation
Hours since the admission to the hospital to normalize the oxygen saturation
Measured: From date of randomization util the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 days
Time of improvement of clinical symptoms (cough, rales)
Hours since the admission to the hospital to have improvement in clinical symptoms
Measured: From date of randomization util the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 days
Time of improvement of fever
Hours to have normal temperature since the admission to the hospital
Measured: From date of randomization util the date of first documented progression, assessed up to 10 days
Duration of hospitalization
Days for the discharge of the patient
Measured: From date of randomization util the date of discharge or date of death from any cause, whichever came first, assessed up to 10 days
Secondary outcomes (2)
Cytokines pattern measured by flow cytometry in blood samples
Th1 cytokines (interferon gamma, IL-2, tumor necrosis factor alfa) and Th2 cytokines (IL-4, IL-10, IL-6) will be determined in blood samples in 2 times: at the admission of the patient and at the discharge
Measured: From date of randomization until de date of discharge or date of death from any cause, whichever came first, assessed up to 10 days
Lymphoproliferation measured by incorporation of a fluorochrome in lymphocytes stimulated with Concanavalin A
Blood draws will be taken at the hospital admission and at the discharge of the patient to measure the lymphoproliferative capacity of their lymphocytes by flow cytometry
Measured: From date of randomization until de date of discharge or date of death from any cause, whichever came first, assessed up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start29 Jan 2014
- Primary completion18 Feb 2016
- Study completion23 Feb 2016
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 PneumoniaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Autonoma de Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital General de Mexico, Hospital Pediatrico de Coyoacan
- Responsible party
- Principal investigator, Rosa Maria Wong Chew, Universidad Nacional Autonoma de Mexico
- Investigators
- Rosa M Wong-Chew, MD, DSc, Principal investigator, Facultad de Medicina, Universidad Nacional Autonoma de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690583
- Sponsor's protocol ID
- CONACYT SALUD 2012-01-182274
- Status last verified
- Sep 2018
- First submitted
- 20 Sep 2018
- Last updated
- 1 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Acevedo-Murillo JA, Garcia Leon ML, Firo-Reyes V, Santiago-Cordova JL, Gonzalez-Rodriguez AP, Wong-Chew RM. Zinc Supplementation Promotes a Th1 Response and Improves Clinical Symptoms in Fewer Hours in Children With Pneumonia Younger Than 5 Years Old. A Randomized Controlled Clinical Trial. Front Pediatr. 2019 Nov 14;7:431. doi: 10.3389/fped.2019.00431. eCollection 2019.
PubMed 31803694
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Immunomodulatory Effect of Zinc Supplementation on the Clinical Evolution of Children With Pneumonia
- ClinicalTrials.gov ID
- NCT03690583
- Acronym / sponsor ID
- CONACYT SALUD 2012-01-182274
- Conditions
- Pneumonia, Children, Only
- Keywords
- Pneumonia, Zinc supplementation, Cytokines, Lymphoproliferation, Viruses, Respiratory bacteria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Universidad Nacional Autonoma de MexicoUniversity, hospital or other
- Collaborators
- Hospital General de Mexico, Hospital Pediatrico de Coyoacan
- Study start
- 29 Jan 2014 (actual)
- Primary completion
- 18 Feb 2016 (actual)
- Study completion
- 23 Feb 2016 (actual)
- First posted
- 1 Oct 2018 (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.
Pneumonia is one of the main causes of morbidity and mortality in the world, especially in developing countries like ours.
The National Health and Nutrition Survey of Mexico, in 2006 showed underweight in 472,890 (5%) children under five years, low height in 1,194,805 (12.7%) and wasting in153,000 (1.6%) children. Zinc is decreased in malnutrition and is an essential cofactor for many proteins involved in cellular processes. Zinc deficiency leads to a decrease in the number of T cells, the ratio of Th1 to Th2 cells and the production of Th1 cytokines such as interferon gamma, with alteration in T cell mediated immunity. In malnourished children zinc supplementation restores the immune response. Reports of zinc supplementation in children with pneumonia are controversial.
The aims of this study are to evaluate the immunomodulatory effect of zinc supplementation in the clinical course of children with pneumonia, to evaluate the lymphoproliferative and cytokine response in these children and to explore whether the viral or bacterial etiology is related to the clinical response to supplementation with this micronutrient.
A clinical, randomized, prospective, controlled, double blinded study will be carried out. Children from 1 month to 5 years of age will be included, with the clinical and / or radiological diagnosis of pneumonia that enter the emergency room of the participant institutions. Empirical treatment for pneumonia will begin and each patient will be randomized 1:1 in 2 groups. One will receive zinc supplementation and another a placebo (glucose). Samples will be taken to determine the etiology (nasal lavage for multiplex polymerase chain reaction for 16 respiratory viruses and 6 bacteria) and a blood sample to measure the cytokine pattern and the lymphoproliferative response. After 7 days of treatment, a second sample will be taken for immunological studies (cytokine pattern and lymphoproliferative response). The following parameters will be measured to evaluate the clinical evolution: respiratory rate, temperature, oxygen saturation, inability to eat, duration of cough, rales, temperature normalization time, normalization time of oxygen saturation, normalization time of the respiratory rate, hospitalization time and outcome (discharge due to clinical improvement or death). A correlation will be made between the improvement in clinical parameters and mortality in the zinc supplementation group and the probable bacterial or viral etiology.
Detailed description
Background: Pneumonia is one of the main causes of morbidity and mortality in the world, especially in developing countries like ours. Of an estimated 8.795 million deaths in children under 5 in the world in 2008, 68% were infectious causes, with the highest percentage due to pneumonia in 18%, followed by diarrhea in 15% and malaria in 8%, 41% of the deaths were in neonates, pneumonia being the 4th cause of death in this age group. Acute respiratory infections, diarrhea and malnutrition together cause 10% of deaths among children under 1 year of age. In Mexico, a pneumonia mortality rate of 120 per 100,000 inhabitants is reported in children under 1 year of age, and 5 deaths per 100,000 inhabitants in children from 1 to 4 years of age in 2007.
The results of the National Health and Nutrition Survey (ENSANUT), carried out in 2006 by the National Institute of Public Health, showed that 472,890 children under five years of age were classified as underweight (5%), 1,194,805 with low height (12.7%) and around 153,000 children with wasting (1.6%). The overall prevalence of anemia in urban areas was 22.8%, while in rural areas was 26.1%. Likewise, it is known that there are specific deficiencies of some micronutrients, such as vitamin A, C, E, zinc, iron, folic acid and iodine, among others. Malnourished children loose between 12 and 15% of their intellectual potential, have a higher risk of infectious diseases 8 to 12 times more than a healthy child and are more prone to chronic degenerative diseases. Malnutrition causes among others an effect of immunosuppression. One of the micronutrients that is decreased in malnutrition is zinc. Zinc is an essential cofactor for many proteins involved in cellular processes such as differentiation, proliferation and apoptosis. During zinc deficiency, the development of T lymphocytes, the polarization in effector cells and their function are altered. This leads to a decrease in the number of T cells, a decrease in the ratio of Th1 to Th2 cells with a decrease in the production of Th1 cytokines such as interferon gamma, and alteration in the defense mediated by T cells. In malnourished children zinc supplementation restores the immune response. Reports of zinc supplementation in children with infectious diseases are controversial. A study in Uganda reports that supplementation with zinc in children from 6 months to 5 years of age with severe pneumonia decreased the mortality from 12% to 4%, with a relative risk reduction of 0.67. Cellular immunity plays a very important role in the defense of the host against viruses and bacteria, zinc supplementation in children who have some degree of malnutrition and who suffer a serious infection could improve the immune response and improve the ability to respond to acute infection.
The aim of this study is to evaluate the immunomodulatory effect of zinc supplementation in the clinical course of children with pneumonia, to evaluate the lymphoproliferative and cytokine response in these children and to explore whether the viral or bacterial etiology is related to the clinical response to supplementation with this micronutrient.
Methods: This is a clinical, randomized, prospective, controlled, double blinded study. Children from 1 month to 5 years of age will be included, with the clinical and / or radiological diagnosis of pneumonia that enter the emergency room of the participant institutions. Empirical treatment for pneumonia will begin and each patient will be randomized 1:1 in 2 groups. One will receive zinc supplementation (10 mg of zinc sulfate in children younger than 1 year old and 20 mg of zinc sulfate in children older than 1 year old) and another a placebo (glucose 10 mg). Samples will be taken to determine the etiology (pharyngeal exudate, nasal lavage for multiplex polymerase chain reaction for 16 respiratory viruses and 6 bacteria) and a blood sample to measure the cytokine pattern and the lymphoproliferative response. After 7 days of treatment, a second sample will be taken for immunological studies (cytokine pattern and lymphoproliferative response). The following parameters will be measured to evaluate the clinical evolution: respiratory rate, temperature, oxygen saturation, inability to eat, duration of cough, crackling, temperature normalization time, normalization time of oxygen saturation, normalization time of the respiratory rate, hospitalization time and outcome (discharge due to clinical improvement or death). A correlation will be made between the improvement in clinical parameters and mortality in the zinc supplementation group and the probable bacterial or viral etiology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zinc group | Experimental | Drug: Zinc sulfateZinc sulfate 10 mg in children younger than 1 year old, 20 mg in children older than 1 year old |
| Placebo group | Placebo comparator | Other: GlucoseGlucose |
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children 1 month to 5 years old with clinical and/or radiological diagnosis of pneumonia
- Admitted to the Emergency room at the participant institutions
Key exclusion criteria (4 listed)
- Prematurity
- Cardiopathy
- Pneumopathy
- Immunosuppression (congenital, chemotherapy or other cause)
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 |
|---|---|---|
| Zinc sulfateAlso: ZincZinc sulfate 10 mg for children younger than 1 year old, 20 mg for children older than 1 year old, will be diluted in 1 ml of sterile water and administered orally every day in the morning during hospitalization | Drug | Zinc group |
| GlucoseThe placebo group will receive glucose diluted in 1 ml of sterile water orally every day during hospitalization | Other | Placebo group |
Primary outcome
Time of improvement of respiratory distress
Time frame: From date of randomization util the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 days
Hours since the admission to the hospital to disappear the respiratory distress
Time of improvement of oxygen desaturation
Time frame: From date of randomization util the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 days
Hours since the admission to the hospital to normalize the oxygen saturation
Time of improvement of clinical symptoms (cough, rales)
Time frame: From date of randomization util the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 days
Hours since the admission to the hospital to have improvement in clinical symptoms
Time of improvement of fever
Time frame: From date of randomization util the date of first documented progression, assessed up to 10 days
Hours to have normal temperature since the admission to the hospital
Duration of hospitalization
Time frame: From date of randomization util the date of discharge or date of death from any cause, whichever came first, assessed up to 10 days
Days for the discharge of the patient
2 secondary outcomes
Cytokines pattern measured by flow cytometry in blood samples
Time frame: From date of randomization until de date of discharge or date of death from any cause, whichever came first, assessed up to 10 days
Lymphoproliferation measured by incorporation of a fluorochrome in lymphocytes stimulated with Concanavalin A
Time frame: From date of randomization until de date of discharge or date of death from any cause, whichever came first, assessed up to 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2018.
- Derived from this study: PubMed 31803694Acevedo-Murillo JA, Garcia Leon ML, Firo-Reyes V, Santiago-Cordova JL, Gonzalez-Rodriguez AP, Wong-Chew RM. Zinc Supplementation Promotes a Th1 Response and Improves Clinical Symptoms in Fewer Hours in Children With Pneumonia Younger Than 5 Years Old. A Randomized Controlled Clinical Trial. Front Pediatr. 2019 Nov 14;7:431. doi: 10.3389/fped.2019.00431. eCollection 2019.
- 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.
Rosa M Wong-Chew, MD, DSc principal investigator
Facultad de Medicina, Universidad Nacional Autonoma de Mexico
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zinc sulfate and Glucose in people with Pneumonia and Children, Only, run by Universidad Nacional Autonoma de Mexico at 2 sites in Mexico.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 1 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of improvement of respiratory distress (time frame: From date of randomization util the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 days). The study lists 5 primary outcomes in all. 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 NCT03690583, 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 1 Oct 2018.