Covid-19Phase 3PaTS-COVIDNCT04703608
Prevention and Treatment for COVID -19 (Severe Acute Respiratory Syndrome Coronavirus 2 SARS-CoV-2) Associated Severe Pneumonia in the Gambia
A Phase 3 study testing Ivermectin and ASP in people with Covid-19, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
Trial summary
The trial aims to assess the impact of cheap, licenced and widely available investigational products on the natural history of SARS-CoV-2 infection in 2 groups of patients - those with mild or moderate pneumonia (Cohort 1) and those with severe pneumonia (Cohort 2), through randomisation to non-identical placebo or… Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Covid-19
- What is being tested?
- Ivermectin and ASP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,200 participants
- Where
- 1 siteThe Gambia
- Study dates
- 22 Jan 2021to Jul 2022
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cohort 1:
- Index case - Individuals ≥ 5 years of age with confirmed COVID19 mild disease or moderate pneumonia defined as:
- Mild disease - Influenza like illness, with any of the following symptoms cough, fever, headache, sore throat, nasal congestion/runny nose, body pains (myalgia), fatigue (malaise), diarrhoea, abdominal pain, anorexia, nausea or vomiting without evidence of pneumonia or hypoxia
- Moderate pneumonia -Clinical signs of pneumonia (fever, cough, dyspnoea, fast breathing) with no need for supplemental oxygen (oxygen saturation ≥90%% on room air or RR between 20 and 30bpm).
- Household contacts - Individuals ≥ 5 years of age living in the same household with the index cases from cohort 1 will be offered to participate into the study. Living in the same household is defined as those individuals who are planning to sleep in and eat from same 'cooking pot' during the following 2 weeks.
- Cohort 2:
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- Individuals ≥12 years of age with suspected or confirmed COVID-19 associated severe pneumonia defined as signs of pneumonia (fever, cough, dyspnoea or fast breathing) plus one of: oxygen saturation (SpO2) <90% on room air OR respiratory rate > 30 breaths/minute
- Suspected COVID-19 disease is defined as clinically or radiologically suspected as determined by the most senior clinician available:
- Clinically suspected Signs and symptoms of pneumonia (as defined above) AND patient living in or recent travel to region with community transmission OR close contact with known COVID-19 patient AND no alternative diagnosis to explain the clinical picture OR
- Radiologically suspected Typical radiological signs of COVID-19 on chest X-ray or lung ultrasound
Who cannot join
- Pregnant women will be excluded from both Cohort 1 and Cohort 2. Patients with allergies to the investigational products will be excluded Cohort 1 (Ivermectin) Lactating mothers will be excluded
- Cohort 2 (aspirin):
- Taking aspirin or other non steroidal anti-inflammatory drugs for any reason.
- Any bleeding disorder (e.g. frequent nose bleeds, haemophilia)
- Active or recurrent peptic ulcer disease (defined as currently on triple therapy or had more than 1 course of triple therapy in the past 12 months. Do not count symptoms of gastritis or on omeprazole as peptic ulcer disease)
- Current active gastrointestinal haemorrhage
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- Severe liver disease or severe kidney disease (severe liver disease defined as cirrhosis with portal hypertension and history of variceal bleeding; severe kidney disease defined as stage 4/5 KD, eGFR <30ml/min)
- Gout
- Suspected intra-cerebral haemorrhage
- Diagnosed with a stroke on this admission
Trial locations and contacts
1 site in 1 country.
The Gambia1 site, 1 recruiting
- Recruiting
Mrcg@Lshtm
Fajara
Effua Usuf, MBChB, +2204495442-6 ext. 5014, eusuf@mrc.gm
Behzad Nadjm, MBChB, +2204495442-6 ext. 2123, bnadjm@mrc.gm
About this study
Official title: Prevention and Treatment for COVID -19 Associated Severe Pneumonia in The Gambia: a Single-Blinded Randomised Clinical Trial (PaTS-COVID)
The trial aims to assess the impact of cheap, licenced and widely available investigational products on the natural history of SARS-CoV-2 infection in 2 groups of patients - those with mild or moderate pneumonia (Cohort 1) and those with severe pneumonia (Cohort 2), through randomisation to non-identical placebo or intervention arm.
Read the detailed description
The trial is adaptive in design, with the option to change the investigational products should evidence change on the benefits/harms of the interventions being trialed.
Cohort 1. Currently index cases with mild COVID-19 or moderate pneumonia will be randomized to ivermectin 0.3-0.4mg/Kg daily for 3 days (arms 1 and 2) or non-identical placebo (arm 3). Index case randomization will also include HH members who will be treated with ivermectin 0.3-0.4mg/Kg daily for 3 days (arm 1) or non-identical placebo (arms 2 and 3). All households will receive a preventative package (containing soap, bleach, cloth facemasks and instructions on their use).
Cohort 2. Patients admitted to hospital meeting WHO criteria for severe COVID-19 pneumonia will be randomized to aspirin 150mg daily or non-identical placebo for 28 days or until hospital discharge (whichever is sooner). Other care will follow National guidelines.
The study will be conducted at multiple sites in The Gambia, with the option to recruit from other West African countries should this be necessary (subject to further local ethical review/s).
- Conditions
- Covid-19
- Being tested
- Ivermectin, ASP, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvermectinDrug
Ivermectin 0.3-0.4mg/Kg daily for 3 days.
ASPDrug
Aspirin 150mg daily for 28 days or until hospital discharge (whichever is sooner)
PlaceboDrug
Non-identical placebo
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 of Cohort 1 | Experimental | Index Case / Household members Ivermectin / Ivermectin (with preventative package) Receives: Drug: Ivermectin |
| Arm 2 of Cohort 1 | Experimental | Index Case / Household members Ivermectin / Placebo (with preventative package) Receives: Drug: Ivermectin; Drug: Placebo |
| Arm 3 of Cohort 1 | Placebo comparator | Index Case / Household members Placebo / Placebo (with preventative package) Receives: Drug: Placebo |
| Arm 1 of Cohort 2 | Experimental | Aspirin 150mg daily for 28 days or until hospital discharge or death (whichever is sooner) Receives: Drug: ASP |
| Arm 2 of Cohort 2 | Placebo comparator | Non identical placebo; doses as per above Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1 Index Case: Percentage of patients with COVID-19 associated mild disease/moderate pneumonia progressing to severe pneumonia [Time frame 14 days]
Percentage of patients with COVID-19 associated mild disease/moderate pneumonia progressing within 14 days after recruitment into severe pneumonia (as per WHO definitions of severity, for each age group)
Measured: 14 days
Cohort 1 Household contacts: Percentage of HH members that get infected with SARS-CoV-2 [Time frame 14 days]
Percentage of HH members that get infected with SARS-CoV-2 during the 14 days following recruitment (defined as those RT-PCR and IgM/IgG negative at day 1 who become positive either by RT-PCR or IgM/IgG by day 14)
Measured: 14 days
Cohort 2: Percentage of COVID-19 associated severe pneumonia patients worsening their condition [Time frame at discharge or day 28 (whichever is first)]
Percentage of COVID-19 associated severe pneumonia patients meeting the criteria of failure defined as worsening their condition from baseline (on admission) for a period of at least 24 hours, scale as follows:
- On or requiring supplemental oxygen given by nasal cannula or face mask to maintain SpO2 within target range
- On or requiring non-invasive (eg CPAP or BiPAP) or invasive ventilatory support to maintain SpO2 within target range (or not maintaining SpO2 within target range with supplemental oxygen given by nasal cannula or face mask)
- Death during hospitalization
Measured: up to 28 days
Secondary outcomes (15)
Cohort1 Index cases: Days from recruitment to virological clearance [Time frame 28 days]
- Days from recruitment to virological clearance defined as one negative SARS-CoV2 virus RT-PCRs.
Measured: 28 days
Days from recruitment until clinical recovery
- Days from recruitment until clinical recovery defined as two consecutive days of no fever (T ≤37.50C) and normal respiratory rate (as per normal range for age and WHO definitions) (only once if day 28 as end of follow-up
Measured: 28 days
- IgG geometric mean titre (GMT) at day 14 and 28 after recruitment [Time frame 14 days and 28 days]
Measured: 14 days and 28 days
Household contacts IgG geometric mean titre (GMT) at day 14 after recruitment [Time frame 14 days]
Measured: 14 days
Percentage of HH members infected that develop COVID19 symptoms [Time frame 14 days]
(defined as those asymptomatic at day 1 that become symptomatic by day 14 (COVID-19 positive either by RT-PCR or IgM/IgG and meet criteria for Cohort 1 index case or cohort 2)
Measured: 14 days
Cohort 2 - Hours from recruitment to hospital discharge [Time frame at discharge]
Measured: up to 28 days
- Hours of duration on oxygen supplementation [Time frame at discharge or day 28 (whichever is first)]
Measured: at discharge or day 28 (whichever is first)
- Death ratio during hospitalization [Time frame at time of death]
Measured: up to 28 days
- Death ratio at 28 days after enrolment [Time frame 28 days]
Measured: 28 days
- Death ratio at 90 days after enrolment [Time frame 90 days]
Measured: 90 days
- Occurrence of clinical thrombotic and embolic events (myocardial infarction, pulmonary embolus, deep venous thrombosis, cerebrovascular accidents). [Time frame 90 days]
Measured: 90 days
- Occurrence of clinical episodes of gastrointestinal bleeding [Time frame 90 days]
Measured: 90 days
- Change in CRP and D-Dimer levels between baseline (enrolment) and day 3-5 [Time frame 5 days]
Measured: enrolment / days 3-5
- Persisting breathlessness at 28 days and 90 days after enrolment [Time frame 28 days/90 days ]
Measured: at 28 day and at 90 day
- Self-reported health at 28 days and 90 days [Time frame 28 days/ 90 days]
Poor self-reported health assessed by a linear self-reported health scale from the EQ-5D questionnaire in person or by telephone
Measured: at 28 days and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start22 Jan 2021
- Primary completionMar 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid-19Studies 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
- Two cohorts study as follows: * Cohort 1: intervention with Ivermectin * Cohort 2: intervention with Aspirin Parallel assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Effua Usuf, MBChB, PhD, Principal investigator, Medical Research Council The Gambia at London School of Hygiene & Tropical MedicineBehzad Nadjm, MBChB, FRCP, Principal investigator, Medical Research Council The Gambia at London School of Hygiene & Tropical MedicineAnna Roca, PhD, Study director, Medical Research Council The Gambia at London School of Hygiene & Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703608
- Sponsor's protocol ID
- LEO 22628
- Acronym
- PaTS-COVID
- Status last verified
- Jun 2021
- First submitted
- 6 Jan 2021
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fischer AL, Messer S, Riera R, Martimbianco ALC, Stegemann M, Estcourt LJ, Weibel S, Monsef I, Andreas M, Pacheco RL, Skoetz N. Antiplatelet agents for the treatment of adults with COVID-19. Cochrane Database Syst Rev. 2023 Jul 25;7(7):CD015078. doi: 10.1002/14651858.CD015078.
PubMed 37489818Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PubMed 34473343
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Treatment for COVID -19 Associated Severe Pneumonia in The Gambia: a Single-Blinded Randomised Clinical Trial (PaTS-COVID)
- ClinicalTrials.gov ID
- NCT04703608
- Acronym / sponsor ID
- PaTS-COVID / LEO 22628
- Conditions
- Covid-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 11 Jan 2021 (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.
The trial aims to assess the impact of cheap, licenced and widely available investigational products on the natural history of SARS-CoV-2 infection in 2 groups of patients - those with mild or moderate pneumonia (Cohort 1) and those with severe pneumonia (Cohort 2), through randomisation to non-identical placebo or intervention arm.
Detailed description
The trial is adaptive in design, with the option to change the investigational products should evidence change on the benefits/harms of the interventions being trialed.
Cohort 1. Currently index cases with mild COVID-19 or moderate pneumonia will be randomized to ivermectin 0.3-0.4mg/Kg daily for 3 days (arms 1 and 2) or non-identical placebo (arm 3). Index case randomization will also include HH members who will be treated with ivermectin 0.3-0.4mg/Kg daily for 3 days (arm 1) or non-identical placebo (arms 2 and 3). All households will receive a preventative package (containing soap, bleach, cloth facemasks and instructions on their use).
Cohort 2. Patients admitted to hospital meeting WHO criteria for severe COVID-19 pneumonia will be randomized to aspirin 150mg daily or non-identical placebo for 28 days or until hospital discharge (whichever is sooner). Other care will follow National guidelines.
The study will be conducted at multiple sites in The Gambia, with the option to recruit from other West African countries should this be necessary (subject to further local ethical review/s).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
- Model description
- Two cohorts study as follows: * Cohort 1: intervention with Ivermectin * Cohort 2: intervention with Aspirin Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Arm 1 of Cohort 1 | Experimental | Drug: IvermectinIndex Case / Household members Ivermectin / Ivermectin (with preventative package) |
| Arm 2 of Cohort 1 | Experimental | Drug: Ivermectin, Drug: PlaceboIndex Case / Household members Ivermectin / Placebo (with preventative package) |
| Arm 3 of Cohort 1 | Placebo comparator | Drug: PlaceboIndex Case / Household members Placebo / Placebo (with preventative package) |
| Arm 1 of Cohort 2 | Experimental | Drug: ASPAspirin 150mg daily for 28 days or until hospital discharge or death (whichever is sooner) |
| Arm 2 of Cohort 2 | Placebo comparator | Drug: PlaceboNon identical placebo; doses as per above |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Cohort 1:
- Index case - Individuals ≥ 5 years of age with confirmed COVID19 mild disease or moderate pneumonia defined as:
- Mild disease - Influenza like illness, with any of the following symptoms cough, fever, headache, sore throat, nasal congestion/runny nose, body pains (myalgia), fatigue (malaise), diarrhoea, abdominal pain, anorexia, nausea or vomiting without evidence of pneumonia or hypoxia
- Moderate pneumonia -Clinical signs of pneumonia (fever, cough, dyspnoea, fast breathing) with no need for supplemental oxygen (oxygen saturation ≥90%% on room air or RR between 20 and 30bpm).
- Household contacts - Individuals ≥ 5 years of age living in the same household with the index cases from cohort 1 will be offered to participate into the study. Living in the same household is defined as those individuals who are planning to sleep in and eat from same 'cooking pot' during the following 2 weeks.
Key exclusion criteria (10 listed)
- Pregnant women will be excluded from both Cohort 1 and Cohort 2. Patients with allergies to the investigational products will be excluded Cohort 1 (Ivermectin) Lactating mothers will be excluded
- Taking aspirin or other non steroidal anti-inflammatory drugs for any reason.
- Any bleeding disorder (e.g. frequent nose bleeds, haemophilia)
- Active or recurrent peptic ulcer disease (defined as currently on triple therapy or had more than 1 course of triple therapy in the past 12 months. Do not count symptoms of gastritis or on omeprazole as peptic ulcer disease)
- Current active gastrointestinal haemorrhage
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 |
|---|---|---|
| IvermectinIvermectin 0.3-0.4mg/Kg daily for 3 days. | Drug | Arm 1 of Cohort 1, Arm 2 of Cohort 1 |
| ASPAspirin 150mg daily for 28 days or until hospital discharge (whichever is sooner) | Drug | Arm 1 of Cohort 2 |
| PlaceboNon-identical placebo | Drug | Arm 2 of Cohort 1, Arm 2 of Cohort 2, Arm 3 of Cohort 1 |
Primary outcome
Cohort 1 Index Case: Percentage of patients with COVID-19 associated mild disease/moderate pneumonia progressing to severe pneumonia [Time frame 14 days]
Time frame: 14 days
Percentage of patients with COVID-19 associated mild disease/moderate pneumonia progressing within 14 days after recruitment into severe pneumonia (as per WHO definitions of severity, for each age group)
Cohort 1 Household contacts: Percentage of HH members that get infected with SARS-CoV-2 [Time frame 14 days]
Time frame: 14 days
Percentage of HH members that get infected with SARS-CoV-2 during the 14 days following recruitment (defined as those RT-PCR and IgM/IgG negative at day 1 who become positive either by RT-PCR or IgM/IgG by day 14)
Cohort 2: Percentage of COVID-19 associated severe pneumonia patients worsening their condition [Time frame at discharge or day 28 (whichever is first)]
Time frame: up to 28 days
Percentage of COVID-19 associated severe pneumonia patients meeting the criteria of failure defined as worsening their condition from baseline (on admission) for a period of at least 24 hours, scale as follows: * On or requiring supplemental oxygen given by nasal cannula or face mask to maintain SpO2 within target range * On or requiring non-invasive (eg CPAP or BiPAP) or invasive ventilatory support to maintain SpO2 within target range (or not maintaining SpO2 within target range with supplemental oxygen given by nasal cannula or face mask) * Death during hospitalization
15 secondary outcomes
Cohort1 Index cases: Days from recruitment to virological clearance [Time frame 28 days]
Time frame: 28 days
Days from recruitment until clinical recovery
Time frame: 28 days
- IgG geometric mean titre (GMT) at day 14 and 28 after recruitment [Time frame 14 days and 28 days]
Time frame: 14 days and 28 days
Household contacts IgG geometric mean titre (GMT) at day 14 after recruitment [Time frame 14 days]
Time frame: 14 days
Percentage of HH members infected that develop COVID19 symptoms [Time frame 14 days]
Time frame: 14 days
Cohort 2 - Hours from recruitment to hospital discharge [Time frame at discharge]
Time frame: up to 28 days
- Hours of duration on oxygen supplementation [Time frame at discharge or day 28 (whichever is first)]
Time frame: at discharge or day 28 (whichever is first)
- Death ratio during hospitalization [Time frame at time of death]
Time frame: up to 28 days
- Death ratio at 28 days after enrolment [Time frame 28 days]
Time frame: 28 days
- Death ratio at 90 days after enrolment [Time frame 90 days]
Time frame: 90 days
- Occurrence of clinical thrombotic and embolic events (myocardial infarction, pulmonary embolus, deep venous thrombosis, cerebrovascular accidents). [Time frame 90 days]
Time frame: 90 days
- Occurrence of clinical episodes of gastrointestinal bleeding [Time frame 90 days]
Time frame: 90 days
- Change in CRP and D-Dimer levels between baseline (enrolment) and day 3-5 [Time frame 5 days]
Time frame: enrolment / days 3-5
- Persisting breathlessness at 28 days and 90 days after enrolment [Time frame 28 days/90 days ]
Time frame: at 28 day and at 90 day
- Self-reported health at 28 days and 90 days [Time frame 28 days/ 90 days]
Time frame: at 28 days and 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Derived from this study: PubMed 37489818Fischer AL, Messer S, Riera R, Martimbianco ALC, Stegemann M, Estcourt LJ, Weibel S, Monsef I, Andreas M, Pacheco RL, Skoetz N. Antiplatelet agents for the treatment of adults with COVID-19. Cochrane Database Syst Rev. 2023 Jul 25;7(7):CD015078. doi: 10.1002/14651858.CD015078.
- Derived from this study: PubMed 34473343Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
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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.
Effua Usuf, MBChB, PhD principal investigator
Medical Research Council The Gambia at London School of Hygiene & Tropical Medicine
Behzad Nadjm, MBChB, FRCP principal investigator
Medical Research Council The Gambia at London School of Hygiene & Tropical Medicine
Anna Roca, PhD study director
Medical Research Council The Gambia at London School of Hygiene & Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ivermectin and ASP in people with Covid-19, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
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 10 inclusion and 10 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 4 Jun 2021. 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 The Gambia. 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 Anna Roca, PhD (+220 4495442 ext. 2305, aroca@mrc.gm), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort 1 Index Case: Percentage of patients with COVID-19 associated mild disease/moderate pneumonia progressing to severe pneumonia [Time frame 14 days] (time frame: 14 days). The study lists 3 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 NCT04703608, which also lists 2 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 4 Jun 2021.