Covid19NCT04617119
The Effects of Multi-modality Physiotherapy in Delaying or Preventing COVID-19 Patient From Admitting to ICU
A study testing Threshold IMT device and Conventional physical therapy in people with Covid19 and Severe Systemic Illness Respiratory Muscle Fatigue, run by DR. JASSIM ALGHAITH at 1 site in Kuwait.
Trial summary
This study aims to evaluate the effectiveness of respiratory muscle training with COVID-19 patient, who has underlying health conditions, in order to delay or prevent them from admitting to ICU. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19, Severe Systemic Illness Respiratory Muscle Fatigue
- What is being tested?
- Threshold IMT device and Conventional physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteKuwait
- Study dates
- 1 Nov 2020to 6 Apr 2021
- Phase
- Interventional
- 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non- intubated patient diagnosed with moderate to severe pneumonia (confirmed by chest x-ray and officially reported) as secondary to COVID-19 with one more symptom such as:
- Respiratory rate at ≥ 20 breath.min-1.
- Oxygen saturation (SatO2) ≤ 90% at rest on room air.
- Arterial partial pressure of oxygen (PaO2) ≤ 80 mmHg at resting.
- PaO2/FiO2 ratio or P/F (is the ratio between the arterial partial pressure of oxygen and the percentage of oxygen supplied) < 300mmHg.
Who cannot join
- Patient that has received upper abdominal or thoracic surgery recently (≤ 3 months).
- Cancer patients.
- Pregnant patients.
- Patient mentally unstable.
- Patient with unstable cardiovascular or neurological functions.
- Patients refusing to participate in this clinical trial.
- Patient less the 21 years old (According to Kuwaiti Law).
- Patients who have a language barrier who cannot understand Arabic or English.
Trial locations and contacts
1 site in 1 country.
Abdulaziz Al-Husaini, MSc. contact
About this study
Official title: The Effects of Multi-modality Physiotherapy in Delaying or Preventing COVID-19 Patient From Admitting to ICU: A Pilot Study
This study aims to evaluate the effectiveness of respiratory muscle training with COVID-19 patient, who has underlying health conditions, in order to delay or prevent them from admitting to ICU.
- Being tested
- Threshold IMT device, Conventional physical therapy
- Keywords
- Respiratory muscle strength, Inspiratory muscle training, Respiratory physical therapy, Patient exercise training, Maximal inspiratory pressure
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Threshold IMT deviceDevice
10 breaths X 3 sets, two times a day for 2 weeks. starting intensity 10 % of pre-measured maximal inspiratory pressure.
Conventional physical therapyOther
daily
| Study group | Role | What they receive |
|---|---|---|
| Conventional physical therapy treatment and IMT | Experimental | The conventional physical therapy treatment for COVID-19 patient will be based on patient medical and physical status.
In addition, the patient will receive inspiratory muscle training (IMT) by using a threshold IMT device. Patient will ask to use the device twice daily. In each time, patient will perform 3 sets of 10 breaths with 1-minute rest between sets.
Exercise intensity will start with 10 % of pre-measured maximal inspiratory pressure.
Once the patient successfully completed 30 breath twice a day, the exercise load will increase 5% more in the subsequent training session.
This treatment protocol will perform daily for 2 weeks. Receives: Device: Threshold IMT device; Other: Conventional physical therapy |
| Conventional physical therapy | Active comparator | The conventional physical therapy treatment for COVID-19 patient will be based on patient medical and physical status. Receives: Other: Conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Respiratory muscle performance
Changes in Respiratory muscle performance will be determined by using the Respiratory Pressure Meter device. Patient will perform full inspiration through this device for 1.5 seconds via the mouth (nose occluded). The reading of the negative peak pressure that is maintained for 1 second in the device is a maximal inspiration peak.
Measured: Baseline, 1st week, 2nd week, one month
Secondary outcomes (9)
Blood pressure
Blood pressure measured by electronic BP machine before and after session
Measured: Daily from baseline to hospital discharge (2 weeks)
Heart rate
measured by heart rate monitor before and after session
Measured: Daily from baseline to hospital discharge (2 weeks)
Oxygen saturation
Measured by pulse oximeter before and after session
Measured: Daily from baseline to hospital discharge (2 weeks)
Oxygen supplementation
Number of % of oxygen patient on it before and after session
Measured: Daily from baseline to hospital discharge (2 weeks).
Oxygen flow rate
measuring the number of time where the oxygen above or below 4L/min.
Measured: Daily from baseline to hospital discharge (2 weeks)
Dyspnoea level
By using Borg scale (rating of perceived exertion scale), Possible score range from 0 (nothing) to 10 ( Maximal exertion).
Before and after session.
Measured: Daily from baseline to hospital discharge (2 weeks)
Pain level
By using visual analogue scale. Possible score range from 0 (no pain) to 10 (worst possible pain) Before and after session.
Measured: Daily from baseline to hospital discharge (2 weeks)
Respiratory rate
Measured by Respiratory rate monitor. Before and after session
Measured: Daily from baseline to hospital discharge (2 weeks)
Threshold IMT device
Recording number for breath and sets daily.
Measured: Daily from baseline to 1 month from admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start1 Nov 2020 (estimated)
- Primary completion6 Feb 2021 (estimated)
- Study completion6 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pilot study following a randomized controlled trial design.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DR. JASSIM ALGHAITH
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, DR. JASSIM ALGHAITH, Ministry of Health, Kuwait
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617119
- Sponsor's protocol ID
- JALGHAITH
- Status last verified
- Nov 2020
- First submitted
- 28 Oct 2020
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: not decided yet
Publications
WHO, CORONAVIRUS DISEASE (COVID-19) OUTBREAK: RIGHTS, ROLES AND RESPONSIBILITIES OF HEALTH WORKERS, INCLUDING KEY CONSIDERATIONS FOR OCCUPATIONAL SAFETY AND HEALTH 2020.
Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
PubMed 32109013Cascella M, Rajnik M, Aleem A, Dulebohn SC, Di Napoli R. Features, Evaluation, and Treatment of Coronavirus (COVID-19). 2023 Aug 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554776/
PubMed 32150360Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
PubMed 32091533Arentz M, Yim E, Klaff L, Lokhandwala S, Riedo FX, Chong M, Lee M. Characteristics and Outcomes of 21 Critically Ill Patients With COVID-19 in Washington State. JAMA. 2020 Apr 28;323(16):1612-1614. doi: 10.1001/jama.2020.4326.
PubMed 32191259Livingston E, Bucher K. Coronavirus Disease 2019 (COVID-19) in Italy. JAMA. 2020 Apr 14;323(14):1335. doi: 10.1001/jama.2020.4344. No abstract available.
PubMed 32181795Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
PubMed 32171076Honce R, Schultz-Cherry S. Impact of Obesity on Influenza A Virus Pathogenesis, Immune Response, and Evolution. Front Immunol. 2019 May 10;10:1071. doi: 10.3389/fimmu.2019.01071. eCollection 2019.
PubMed 31134099Bhatraju PK, Ghassemieh BJ, Nichols M, Kim R, Jerome KR, Nalla AK, Greninger AL, Pipavath S, Wurfel MM, Evans L, Kritek PA, West TE, Luks A, Gerbino A, Dale CR, Goldman JD, O'Mahony S, Mikacenic C. Covid-19 in Critically Ill Patients in the Seattle Region - Case Series. N Engl J Med. 2020 May 21;382(21):2012-2022. doi: 10.1056/NEJMoa2004500. Epub 2020 Mar 30.
PubMed 32227758Cai Q, Chen F, Wang T, Luo F, Liu X, Wu Q, He Q, Wang Z, Liu Y, Liu L, Chen J, Xu L. Obesity and COVID-19 Severity in a Designated Hospital in Shenzhen, China. Diabetes Care. 2020 Jul;43(7):1392-1398. doi: 10.2337/dc20-0576. Epub 2020 May 14.
PubMed 32409502Almazeedi S, Al-Youha S, Jamal MH, Al-Haddad M, Al-Muhaini A, Al-Ghimlas F, Al-Sabah S. Characteristics, risk factors and outcomes among the first consecutive 1096 patients diagnosed with COVID-19 in Kuwait. EClinicalMedicine. 2020 Jul 4;24:100448. doi: 10.1016/j.eclinm.2020.100448. eCollection 2020 Jul.
PubMed 32766546American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.
PubMed 12186831Laveneziana P, Albuquerque A, Aliverti A, Babb T, Barreiro E, Dres M, Dube BP, Fauroux B, Gea J, Guenette JA, Hudson AL, Kabitz HJ, Laghi F, Langer D, Luo YM, Neder JA, O'Donnell D, Polkey MI, Rabinovich RA, Rossi A, Series F, Similowski T, Spengler CM, Vogiatzis I, Verges S. ERS statement on respiratory muscle testing at rest and during exercise. Eur Respir J. 2019 Jun 13;53(6):1801214. doi: 10.1183/13993003.01214-2018. Print 2019 Jun.
PubMed 30956204Sood A. Altered resting and exercise respiratory physiology in obesity. Clin Chest Med. 2009 Sep;30(3):445-54, vii. doi: 10.1016/j.ccm.2009.05.003.
PubMed 19700043Castro AA, Calil SR, Freitas SA, Oliveira AB, Porto EF. Chest physiotherapy effectiveness to reduce hospitalization and mechanical ventilation length of stay, pulmonary infection rate and mortality in ICU patients. Respir Med. 2013 Jan;107(1):68-74. doi: 10.1016/j.rmed.2012.09.016. Epub 2012 Oct 22.
PubMed 23085215
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Multi-modality Physiotherapy in Delaying or Preventing COVID-19 Patient From Admitting to ICU: A Pilot Study
- ClinicalTrials.gov ID
- NCT04617119
- Acronym / sponsor ID
- JALGHAITH
- Keywords
- Respiratory muscle strength, Inspiratory muscle training, Respiratory physical therapy, Patient exercise training, Maximal inspiratory pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- DR. JASSIM ALGHAITHOther government
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 6 Feb 2021 (estimated)
- Study completion
- 6 Apr 2021 (estimated)
- First posted
- 5 Nov 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 evaluate the effectiveness of respiratory muscle training with COVID-19 patient, who has underlying health conditions, in order to delay or prevent them from admitting to ICU.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A pilot study following a randomized controlled trial design.
| Arm | Type | Receives |
|---|---|---|
| Conventional physical therapy treatment and IMT | Experimental | Device: Threshold IMT device, Other: Conventional physical therapyThe conventional physical therapy treatment for COVID-19 patient will be based on patient medical and physical status. In addition, the patient will receive inspiratory muscle training (IMT) by using a threshold IMT device. Patient will ask to use the device twice daily. In each time, patient will perform 3 sets of 10 breaths with 1-minute rest between sets. Exercise intensity will start with 10 % of pre-measured maximal inspiratory pressure. Once the patient successfully completed 30 breath twice a day, the exercise load will increase 5% more in the subsequent training session. This treatment protocol will perform daily for 2 weeks. |
| Conventional physical therapy | Active comparator | Other: Conventional physical therapyThe conventional physical therapy treatment for COVID-19 patient will be based on patient medical and physical status. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Non- intubated patient diagnosed with moderate to severe pneumonia (confirmed by chest x-ray and officially reported) as secondary to COVID-19 with one more symptom such as:
Key exclusion criteria (8 listed)
- Patient that has received upper abdominal or thoracic surgery recently (≤ 3 months).
- Cancer patients.
- Pregnant patients.
- Patient mentally unstable.
- Patient with unstable cardiovascular or neurological functions.
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 |
|---|---|---|
| Threshold IMT device10 breaths X 3 sets, two times a day for 2 weeks. starting intensity 10 % of pre-measured maximal inspiratory pressure. | Device | Conventional physical therapy treatment and IMT |
| Conventional physical therapydaily | Other | Conventional physical therapy, Conventional physical therapy treatment and IMT |
Primary outcome
Changes in Respiratory muscle performance
Time frame: Baseline, 1st week, 2nd week, one month
Changes in Respiratory muscle performance will be determined by using the Respiratory Pressure Meter device. Patient will perform full inspiration through this device for 1.5 seconds via the mouth (nose occluded). The reading of the negative peak pressure that is maintained for 1 second in the device is a maximal inspiration peak.
9 secondary outcomes
Blood pressure
Time frame: Daily from baseline to hospital discharge (2 weeks)
Heart rate
Time frame: Daily from baseline to hospital discharge (2 weeks)
Oxygen saturation
Time frame: Daily from baseline to hospital discharge (2 weeks)
Oxygen supplementation
Time frame: Daily from baseline to hospital discharge (2 weeks).
Oxygen flow rate
Time frame: Daily from baseline to hospital discharge (2 weeks)
Dyspnoea level
Time frame: Daily from baseline to hospital discharge (2 weeks)
Pain level
Time frame: Daily from baseline to hospital discharge (2 weeks)
Respiratory rate
Time frame: Daily from baseline to hospital discharge (2 weeks)
Threshold IMT device
Time frame: Daily from baseline to 1 month from admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- BackgroundWHO, CORONAVIRUS DISEASE (COVID-19) OUTBREAK: RIGHTS, ROLES AND RESPONSIBILITIES OF HEALTH WORKERS, INCLUDING KEY CONSIDERATIONS FOR OCCUPATIONAL SAFETY AND HEALTH 2020.
- Background: PubMed 32109013Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
- Background: PubMed 32150360Cascella M, Rajnik M, Aleem A, Dulebohn SC, Di Napoli R. Features, Evaluation, and Treatment of Coronavirus (COVID-19). 2023 Aug 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554776/
- Background: PubMed 32091533Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
- Background: PubMed 32191259Arentz M, Yim E, Klaff L, Lokhandwala S, Riedo FX, Chong M, Lee M. Characteristics and Outcomes of 21 Critically Ill Patients With COVID-19 in Washington State. JAMA. 2020 Apr 28;323(16):1612-1614. doi: 10.1001/jama.2020.4326.
- Background: PubMed 32181795Livingston E, Bucher K. Coronavirus Disease 2019 (COVID-19) in Italy. JAMA. 2020 Apr 14;323(14):1335. doi: 10.1001/jama.2020.4344. No abstract available.
- Background: PubMed 32171076Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
- Background: PubMed 31134099Honce R, Schultz-Cherry S. Impact of Obesity on Influenza A Virus Pathogenesis, Immune Response, and Evolution. Front Immunol. 2019 May 10;10:1071. doi: 10.3389/fimmu.2019.01071. eCollection 2019.
- Background: PubMed 32227758Bhatraju PK, Ghassemieh BJ, Nichols M, Kim R, Jerome KR, Nalla AK, Greninger AL, Pipavath S, Wurfel MM, Evans L, Kritek PA, West TE, Luks A, Gerbino A, Dale CR, Goldman JD, O'Mahony S, Mikacenic C. Covid-19 in Critically Ill Patients in the Seattle Region - Case Series. N Engl J Med. 2020 May 21;382(21):2012-2022. doi: 10.1056/NEJMoa2004500. Epub 2020 Mar 30.
- Background: PubMed 32409502Cai Q, Chen F, Wang T, Luo F, Liu X, Wu Q, He Q, Wang Z, Liu Y, Liu L, Chen J, Xu L. Obesity and COVID-19 Severity in a Designated Hospital in Shenzhen, China. Diabetes Care. 2020 Jul;43(7):1392-1398. doi: 10.2337/dc20-0576. Epub 2020 May 14.
- Background: PubMed 32766546Almazeedi S, Al-Youha S, Jamal MH, Al-Haddad M, Al-Muhaini A, Al-Ghimlas F, Al-Sabah S. Characteristics, risk factors and outcomes among the first consecutive 1096 patients diagnosed with COVID-19 in Kuwait. EClinicalMedicine. 2020 Jul 4;24:100448. doi: 10.1016/j.eclinm.2020.100448. eCollection 2020 Jul.
- Background: PubMed 12186831American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.
- Individual participant dataSharing planned: Undecided. not decided yet
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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.
Abdulaziz Al-Husaini, MSc. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Threshold IMT device and Conventional physical therapy in people with Covid19 and Severe Systemic Illness Respiratory Muscle Fatigue, run by DR. JASSIM ALGHAITH at 1 site in Kuwait.
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 5 inclusion and 8 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 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kuwait. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Jassim M Alghaith, PhD. ((965)99558185, Alghaith328@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Respiratory muscle performance (time frame: Baseline, 1st week, 2nd week, one month). 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 NCT04617119, which also lists 26 linked publications.
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 5 Nov 2020.