COVID-19 PneumoniaLLLTNCT05271461
COVID-19 Hyper Coagulability Care by LLLT
A study testing Low level laser Therapy and Circulatory exercises in people with COVID-19 Pneumonia, run by Cairo University at 1 site in Egypt.
Trial summary
COVID-19 clotting Safety Read more about this study
- Who is it for?
- Ages 35 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- Low level laser Therapy and Circulatory exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2022to 4 Jun 2022
- 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 35 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI from 18.5 to 29.9 kg/m2
- Moderate elevated percentage of coagulative factors for COVID-19 Diagnosis:
- Nasopharyngeal swab
- Sepsis induced coagulopathy score>4
- D_dimer≥0,5mg/L
- Fibrinogen>2,5gm/L
Show all 15Show fewer
- C_reactive protein≥10mg/L
- Lymphocyte count<1,500mm3
- Platelet count<150,000mm3
- Prothrombin time increase>3sec
- Activated partial thromboplastin time increase>5sec
- Same level of physical activity
- Patients can swallow tablets
- CT scan screening method for COVID-19 Diagnosis
- Physical examination
Who cannot join
- hyper tension
- Cognitive impairment e.g (delirium)
- Diabetes mellitus both types dependant or non
- Disabled musculoskeletal Disorders e.g hemi paresis
- Coronary artery diseases and heart failure
- DVT
Show all 11Show fewer
- Stroke, bone disease, renal failure, pulmonary embolism
- Vitamins deficiency
- 6 months post large surgeries
- Alcohol intake and smokers
- Thyroid diseases
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Physical therapy faculty
Dokki, Giza Governorate, 12611
Enas Dr Ahmed, Bsc, 01028406164 ext. Therapist, enaswagdydaib@gmail.com
Bsc, 01028406164 ext. Therapist, enaswagdydaib@gmail.com
About this study
Official title: Effect of Low Level Laser Therapy on Hyper Coagulability in Patients With Covid-19
COVID-19 clotting Safety
Read the detailed description
Covid-19 patients have liability for hyper coagulability, low level laser Therapy improve circulation and decrease liability for hyper coagulability accompanied with circulatory exercises .
- Conditions
- COVID-19 Pneumonia
- Being tested
- Low level laser Therapy, Circulatory exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low level laser TherapyRadiation
Pin pointed application of low level laser on 15 acupuncture points each point 1 min time of application 15 min.
Circulatory exercisesOther
Active assisted or against mild resistance. Supine with leg up position 18degrees measured by the bed water balance in side rails.
If patient is not comfortable according to the modified Borg scale or contra indicated for the position then assume the supine position.
The subject will have A 3 min rest period to acclimatize themselves to each position.
The ankle pumping exercises consisted of simple repetitions of dorsiflexion 1 sec and planter- flexion for 1 sec with three different exercise intervals:
- repeated dorsiflexion and planter-flexion with no rest (no rest exercise).
- repeated dorsiflexion and planter-flexion with a 2 sec rest period (2 sec rest exercise).
- repeated dorsiflexion and planter-flexion with 4sec rest period (4sec rest exercise).
Subjects will have practiced ankle pumps before the exercise to get familiar and be educated about the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Circulatory exercises group . | Active comparator | Circulatory exercises. Receives: Other: Circulatory exercises |
| LLLT group . | Experimental | Low level laser Therapy + circulatory exercises. Receives: Radiation: Low level laser Therapy; Other: Circulatory exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulatory group laboratory investigation.
D-dimer≥.5mg/dL, fibrinogen>2.5mg/dL
To examine COVID-19 recovery.
Measured: Monthly (an average of two months)
Circulatory group: CBC analysis.
Lymphocyte count<1.500mm3, Platelet count<150.000mm3, to examine COVID-19 recovery.
Measured: Daily (an average of two months)
Circulatory group (PT, PTT).
Prothrombin time>3 sec, activated partial thromboplastin time>5 sec to examine COVID-19 recovery.
Measured: Bi weekly (an average of two months)
Circulatory group physical examination.
by visual analog scale is horizontal line 100mm length the ends defined as extreme limit of the parameter measured (symptom, pain, health) orientated from the left (the worst) the right (the best) 3 times per week to detect DVT.
Measured: Every two days (an average of two months)
Circulatory group. BMI.
weight kg on height m2 to detect liability for DVT.
Measured: Day one
Especially Lab investigation.
C-reactive protein ≥10mg/l for diagnosis of the recovery.
Measured: Baseline
Secondary outcomes (6)
LLLT group laboratory investigation.
D-dimer≥,5mg/dl, fibrinogen>2.5mg/dl, c-reactive protein≥10mg/dl to examine COVID-19 recovery.
Fibrinogen
Measured: Monthly (an average of two months)
LLLT group CBC analysis.
lymphocyte count<1,500mm3, platelet count<150,000mm3, for examine COVID-19 recovery.
Measured: Daily (an average of two months)
LLLT group. {PTT, PT}.
Prothrombin time>3 sec, activated partial thromboplastin time>5sec to examine COVID-19 recovery.
Measured: Bi weekly (an average of two months)
LLLT group physical examination.
by visual analog scale is a straight horizontal line of fixed length 100mm the end is extreme limit of the parameter measured (symptom, pain, health) orientated from the left (the worst) to the right (the best) 3times per week to detect DVT.
Measured: Every two days (an average of two months)
LLLT group. BMI.
Weight kg/height m2 to detect liability for DVT.
Measured: Day one
Specifically Lab investigation.
C_reactive protein≥10mg/l.help diagnosis of the recovery.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start1 Feb 2022
- Primary completion4 Apr 2022 (estimated)
- Study completion4 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Two groups of 30 patients, 1st circulatory exercise, 2nd LLLT and circulatory exercises.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enas Wagdy Elsaid Ahmed, Cairo University
- Investigators
- Enas Dr Ahmed, BSC, Principal investigator, Physical therapy faculty CairoU.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271461
- Sponsor's protocol ID
- COVID-19 LLLT.
- Acronym
- LLLT
- Status last verified
- Feb 2022
- First submitted
- 14 Feb 2022
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agaiby AD, Ghali LR, Wilson R, Dyson M. Laser modulation of angiogenic factor production by T-lymphocytes. Lasers Surg Med. 2000;26(4):357-63. doi: 10.1002/(sici)1096-9101(2000)26:43.0.co;2-o.
PubMed 10805940Emami A, Javanmardi F, Pirbonyeh N, Akbari A. Prevalence of Underlying Diseases in Hospitalized Patients with COVID-19: a Systematic Review and Meta-Analysis. Arch Acad Emerg Med. 2020 Mar 24;8(1):e35. eCollection 2020.
PubMed 32232218ConnorsJ.M.,LevyJ.H(2020).Thromboinflammation and the hyper coagulability of COVID-19.JThromb Haemost https://doi.org/10.1111/jth.14849.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Level Laser Therapy on Hyper Coagulability in Patients With Covid-19
- ClinicalTrials.gov ID
- NCT05271461
- Acronym / sponsor ID
- LLLT / COVID-19 LLLT.
- Conditions
- COVID-19 Pneumonia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 4 Apr 2022 (estimated)
- Study completion
- 4 Jun 2022 (estimated)
- First posted
- 9 Mar 2022 (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.
COVID-19 clotting Safety
Detailed description
Covid-19 patients have liability for hyper coagulability, low level laser Therapy improve circulation and decrease liability for hyper coagulability accompanied with circulatory exercises .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Two groups of 30 patients, 1st circulatory exercise, 2nd LLLT and circulatory exercises.
| Arm | Type | Receives |
|---|---|---|
| Circulatory exercises group . | Active comparator | Other: Circulatory exercisesCirculatory exercises. |
| LLLT group . | Experimental | Radiation: Low level laser Therapy, Other: Circulatory exercisesLow level laser Therapy + circulatory exercises. |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- BMI from 18.5 to 29.9 kg/m2
- Moderate elevated percentage of coagulative factors for COVID-19 Diagnosis:
- Nasopharyngeal swab
- Sepsis induced coagulopathy score>4
- D_dimer≥0,5mg/L
Key exclusion criteria (11 listed)
- hyper tension
- Cognitive impairment e.g (delirium)
- Diabetes mellitus both types dependant or non
- Disabled musculoskeletal Disorders e.g hemi paresis
- Coronary artery diseases and heart failure
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 |
|---|---|---|
| Low level laser TherapyPin pointed application of low level laser on 15 acupuncture points each point 1 min time of application 15 min. | Radiation | LLLT group . |
| Circulatory exercisesActive assisted or against mild resistance. Supine with leg up position 18degrees measured by the bed water balance in side rails. If patient is not comfortable according to the modified Borg scale or contra indicated for the position then assume the supine position. The subject will have A 3 min rest period to acclimatize themselves to each position. The ankle pumping exercises consisted of simple repetitions of dorsiflexion 1 sec and planter- flexion for 1 sec with three different exercise intervals: * repeated dorsiflexion and planter-flexion with no rest (no rest exercise). * repeated dorsiflexion and planter-flexion with a 2 sec rest period (2 sec rest exercise). * repeated dorsiflexion and planter-flexion with 4sec rest period (4sec rest exercise). Subjects will have practiced ankle pumps before the exercise to get familiar and be educated about the procedure. | Other | Circulatory exercises group ., LLLT group . |
Primary outcome
Circulatory group laboratory investigation.
Time frame: Monthly (an average of two months)
D-dimer≥.5mg/dL, fibrinogen>2.5mg/dL To examine COVID-19 recovery.
Circulatory group: CBC analysis.
Time frame: Daily (an average of two months)
Lymphocyte count<1.500mm3, Platelet count<150.000mm3, to examine COVID-19 recovery.
Circulatory group (PT, PTT).
Time frame: Bi weekly (an average of two months)
Prothrombin time>3 sec, activated partial thromboplastin time>5 sec to examine COVID-19 recovery.
Circulatory group physical examination.
Time frame: Every two days (an average of two months)
by visual analog scale is horizontal line 100mm length the ends defined as extreme limit of the parameter measured (symptom, pain, health) orientated from the left (the worst) the right (the best) 3 times per week to detect DVT.
Circulatory group. BMI.
Time frame: Day one
weight kg on height m2 to detect liability for DVT.
Especially Lab investigation.
Time frame: Baseline
C-reactive protein ≥10mg/l for diagnosis of the recovery.
6 secondary outcomes
LLLT group laboratory investigation.
Time frame: Monthly (an average of two months)
LLLT group CBC analysis.
Time frame: Daily (an average of two months)
LLLT group. {PTT, PT}.
Time frame: Bi weekly (an average of two months)
LLLT group physical examination.
Time frame: Every two days (an average of two months)
LLLT group. BMI.
Time frame: Day one
Specifically Lab investigation.
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Background: PubMed 10805940Agaiby AD, Ghali LR, Wilson R, Dyson M. Laser modulation of angiogenic factor production by T-lymphocytes. Lasers Surg Med. 2000;26(4):357-63. doi: 10.1002/(sici)1096-9101(2000)26:43.0.co;2-o.
- Background: PubMed 32232218Emami A, Javanmardi F, Pirbonyeh N, Akbari A. Prevalence of Underlying Diseases in Hospitalized Patients with COVID-19: a Systematic Review and Meta-Analysis. Arch Acad Emerg Med. 2020 Mar 24;8(1):e35. eCollection 2020.
- BackgroundConnorsJ.M.,LevyJ.H(2020).Thromboinflammation and the hyper coagulability of COVID-19.JThromb Haemost https://doi.org/10.1111/jth.14849.
- 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.
Enas Dr Ahmed, BSC principal investigator
Physical therapy faculty CairoU.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low level laser Therapy and Circulatory exercises in people with COVID-19 Pneumonia, run by Cairo University at 1 site in Egypt.
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 15 inclusion and 11 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 9 Mar 2022. 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 Egypt. 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 Enas Dr Ahmed, BSC (01028406164 ext. Therapist, enaswagdydaib@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulatory group laboratory investigation. (time frame: Monthly (an average of two months)). The study lists 6 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 NCT05271461, which also lists 3 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 9 Mar 2022.