A Multicenter Randomized Controlled Pilot Trial Testing the Efficacy and Safety of Pterygopalatine Fossa Puncture Using One Acupuncture Needle for Moderate-to-Severe Persistent Allergic Rhinitis

Objective. To compare the efficacy and safety of pterygopalatine fossa puncture using one acupuncture needle inserted through the temporal fossa (intervention) and Chinese verum acupuncture (VA) in patients with moderate-to-severe persistent allergic rhinitis. Methods. The patients were randomized to an intervention group receiving pterygopalatine fossa puncture with one acupuncture needle for 4 weeks (once or twice weekly, 4–8 sessions in total, with a second course performed if required) or to a control group receiving individualized VA for 4 weeks (twice weekly, eight sessions in total). Patients were followed up 4 weeks later. Results. Ninety-six participants were assigned to intervention (n = 48) or VA (n = 48) groups. After treatment, differences in the total nasal symptom score (2004 Chinese version), total nonnasal symptom score, Rhinoconjunctivitis Quality of Life Questionnaire score, and symptomatic days were not significant between the groups (P>0.05 in all cases). Compared with the VA, the time to onset of effect in the intervention group was shorter and the duration of effectiveness was longer. The mean clinical waiting time was significantly shorter in the intervention group than in the control group (6.640 ± 3.035 min and 31.19 ± 10.216 min, respectively). The total number of sessions in the VA group was 384; 7 episodes of subcutaneous bleeding occurred but did not require treatment. The total number of sessions in the intervention group was 185. Two cases of subcutaneous bleeding (one of local hematoma during the intervention and the other one of bruising in the palpebra inferior on the day after intervention) resolved upon withdrawal from the study. Conclusions. Pterygopalatine fossa puncture using one acupuncture needle resulted in a shorter time to onset of effect, a longer duration of effectiveness, and less clinical waiting time when compared with VA. Though the significant differences for TNSS and TNNSS were shown within intervention and VA groups, there were no differences between the two groups. Although the rate of subcutaneous bleeding was low, these adverse events may influence patient compliance. This trial is registered with ISRCTN21980724.

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Clinical Efficacy and Safety of Omalizumab in the Treatment of Allergic Rhinitis: A Systematic Review and Meta-analysis of Randomized Clinical Trials

American Journal of Rhinology and Allergy ◽

10.1177/1945892419884774 ◽

2019 ◽

Vol 34 (2) ◽

pp. 196-208 ◽

Cited By ~ 7

Author(s):

Chenjie Yu ◽

Kaijian Wang ◽

Xinyan Cui ◽

Ling Lu ◽

Jianfei Dong ◽

...

Keyword(s):

Allergic Rhinitis ◽

Adverse Events ◽

Symptom Score ◽

Meta Analysis ◽

Cochrane Library ◽

Control Group ◽

Life Questionnaire ◽

Efficacy And Safety ◽

Significant Difference ◽

Symptom Scores

Background Patients with moderate to severe allergic rhinitis (AR) who are treated according to the current rhinitis management guidelines may be inadequately controlled. These patients are at risk of serious comorbidities, such as asthma and chronic sinusitis. These symptoms, sneezing and an itchy, runny, stuffy nose, may have a negative impact on patients’ daily functioning. Omalizumab is being developed as a new choice for the treatment of AR. We therefore undertook a meta-analysis to assess the efficacy and safety of omalizumab in the treatment of AR. Methods We systematically searched PubMed, Cochrane Library, and MEDLINE databases for randomized controlled studies on the treatment of AR with omalizumab. Our evaluation outcomes were symptom scores, medication efficacy, combined symptom and medication scores, and adverse events. We descriptively summarized and quantitatively synthesized original data to evaluate the efficacy and safety of omalizumab in the treatment of AR by using Stata12.0 software for meta-analyses. Results The results of our meta-analysis showed that there were statistically significant differences between the omalizumab group and the control group in the following aspects: daily nasal symptom score (standardized mean difference [SMD] = –0.443, 95% confidence interval [CI]: –0.538 to –0.347, P < .001); daily ocular symptom score (SMD = –0.385, 95% CI: –0.5 to –0.269, P < .001); daily nasal medication symptom scores (SMD = –0.421, 95% CI: –0.591 to –0.251, P < .001); proportion of days of emergency drug use (risk ratio [RR] = 0.488, 95% CI: 0.307 to 0.788, P < .005); rhinoconjunctivitis-specific quality of life questionnaire (SMD = –0.286, 95% CI: –0.418 to –0.154, P < .001); and overall evaluation (RR = 1.435, 95% CI: 1.303–1.582, P < .001). There was no statistically significant difference in safety indicator: adverse events (RR = 1.026, 95% CI: 0.916–1.150, P = .655). Conclusion Omalizumab is effective and relatively safe in patients with AR; omalizumab used in conjunction with special immunotherapy has shown promising results, especially in reducing adverse events.

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Effect of adjunctive sodium hyaluronate versus surfactant nasal irrigation on mucociliary clearance in allergic rhinitis: a single-blind, randomised, controlled study

The Journal of Laryngology & Otology ◽

10.1017/s0022215121000967 ◽

2021 ◽

pp. 1-4

Author(s):

E Ocak ◽

S Mulazimoglu ◽

D Kocaoz ◽

E Mirici ◽

E Dagli ◽

...

Keyword(s):

Allergic Rhinitis ◽

Mucociliary Clearance ◽

Isotonic Saline ◽

Sodium Hyaluronate ◽

Controlled Study ◽

Control Group ◽

Clearance Time ◽

Nasal Irrigation ◽

Persistent Allergic Rhinitis ◽

Randomised Controlled

Abstract Objective To investigate the effects of nasal irrigation with sodium hyaluronate and surfactant solutions on mucociliary clearance time in patients with mild persistent allergic rhinitis. Methods A total of 120 patients diagnosed with mild persistent allergic rhinitis were enrolled in this prospective study. The patients were allocated randomly to the surfactant, sodium hyaluronate or isotonic saline (as a control) nasal irrigation group. The mucociliary clearance times and improvements in mucociliary clearance times were compared. Results Improvements in mean mucociliary clearance time were significantly greater in the surfactant and sodium hyaluronate groups than in the control group (p < 0.01). The mean post-treatment mucociliary clearance time of the surfactant group was significantly lower than that of the control (p < 0.001) and sodium hyaluronate groups (p = 0.03). Conclusion Surfactant and sodium hyaluronate nasal irrigation solutions may both be used as adjunctive treatments for allergic rhinitis. Surfactant nasal irrigation resulted in better mucociliary clearance times.

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Efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia: a protocol for randomised double-blind controlled clinical trial

BMJ Open ◽

10.1136/bmjopen-2020-041958 ◽

2020 ◽

Vol 10 (10) ◽

pp. e041958

Author(s):

Nirmani Yasara ◽

Nethmi Wickramarathne ◽

Chamila Mettananda ◽

Aresha Manamperi ◽

Anuja Premawardhena ◽

...

Keyword(s):

Clinical Trial ◽

Sri Lanka ◽

Intervention Group ◽

Primary Outcome Measure ◽

Control Group ◽

Controlled Clinical Trial ◽

Efficacy And Safety ◽

Scientific Publications ◽

Double Blind ◽

Fetal Haemoglobin

IntroductionDespite being one of the first diseases to be genetically characterised, β-thalassaemia remains a disorder without a cure in a majority of patients. Most patients with β-thalassaemia receive only supportive treatment and therefore have a poor quality of life and shorter life spans. Hydroxyurea, which has shown to induce fetal haemoglobin synthesis in human erythroid cells, is currently recommended for the treatment of sickle cell disease. However, its clinical usefulness in transfusion-dependent β-thalassaemia is unclear. Here, we present a protocol for a randomised double-blind controlled clinical trial to evaluate the efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia.Methods and analysisThis single-centre randomised double-blind placebo-controlled clinical trial is conducted at the Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Adult and adolescent patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into the intervention or control group. The intervention group receives oral hydroxyurea 10–20 mg/kg daily for 6 months, while the control group receives a placebo which is identical in size, shape and colour to hydroxyurea without its active ingredient. Transfused blood volume, pretransfusion haemoglobin level, fetal haemoglobin percentage and adverse effects of treatment are monitored during treatment and 6 months post-treatment. Cessation or reduction of blood transfusions during the treatment period will be the primary outcome measure. The statistical analysis will be based on intention to treat.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of Faculty of Medicine, University of Kelaniya (P/116/05/2018) and the trial is approved by the National Medicinal Regulatory Authority of Sri Lanka. Results of the trial will be disseminated in scientific publications in reputed journals.Trial registration numberSLCTR/2018/024; Pre-results.

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Efficacy and Safety of Bilastine in the Treatment of Allergic Rhinitis: A Systematic Review and Meta-analysis

Frontiers in Pharmacology ◽

10.3389/fphar.2021.731201 ◽

2022 ◽

Vol 12 ◽

Author(s):

Aranjit Singh Randhawa ◽

Norhayati Mohd Noor ◽

Mohd Khairi Md Daud ◽

Baharudin Abdullah

Keyword(s):

Allergic Rhinitis ◽

Symptom Score ◽

Meta Analysis ◽

Nasal Symptom ◽

Comparable Efficacy ◽

Controlled Trials ◽

Cochrane Central Register ◽

Efficacy And Safety ◽

Quality Of Evidence

Bilastine is a non-sedating second generation H1 oral antihistamine (OAH) for treating allergic rhinitis (AR) patients. The effect of bilastine has not previously been evaluated in a meta-analysis. The aim of this review was to determine the efficacy and safety of bilastine in treating AR. An electronic literature search was performed using Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Science Direct and Google Scholar up to March 2021. Randomized controlled trials comparing bilastine with placebo and standard pharmacotherapy were included. The included studies must have diagnosis of AR established by clinicians and the outcomes must have a minimum of 2 weeks of follow-up period. The primary outcomes assessed were total symptom score (TSS), nasal symptom score (NSS) and non-nasal symptom score (NNSS). The secondary outcomes were discomfort due to rhinitis, quality of life (QOL) and adverse events. The risk of bias and quality of evidence for all studies were appraised. The meta-analysis was done using Review Manager 5.3 software based on the random-effects model. The search identified 135 records after removal of duplicates. Following screening and review of the records, fifteen full-text articles were assessed for eligibility. Five trials involving 3,329 patients met the inclusion criteria. Bilastine was superior to placebo in improving TSS, NSS, NNSS, rhinitis discomfort score and QOL but has comparable efficacy with other OAHs in TSS, NSS, NNS, rhinitis discomfort score and QOL. There was no difference in adverse effects when bilastine was compared against placebo and other OAHs except for somnolence. Bilastine has fewer incidence of somnolence compared to cetirizine. The overall quality of evidence ranged from moderate to high quality. Bilastine is effective and safe in treating the overall symptoms of AR with comparable efficacy and safety with other OAHs except somnolence. Whilst bilastine has similar efficacy to cetirizine, somnolence is notably less in bilastine.

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Efektivitas salin hipertonik terhadap waktu transpor mukosiliar dan skor gejala hidung penderita rinitis alergi

Oto Rhino Laryngologica Indonesiana ◽

10.32637/orli.v47i2.221 ◽

2018 ◽

Vol 47 (2) ◽

pp. 123

Author(s):

Woro Safitri ◽

Dwi Reno Pawarti ◽

Titiek Hidayati Ahadiah

Keyword(s):

Clinical Trial ◽

Allergic Rhinitis ◽

Symptom Score ◽

Saline Group ◽

Nasal Symptom ◽

Control Group ◽

Mucociliary Transport ◽

Transport Time ◽

Total Nasal Symptom Score ◽

The Mean

Latar belakang: Rinitis alergi (RA) adalah suatu penyakit inflamasi mukosa hidung yang diperantara oleh imunoglobulin E (IgE), setelah mukosa hidung terpapar alergen. Tujuan: Mengidentifikasi efektivitas cuci hidung salin hipertonik terhadap waktu transpor mukosiliar dan skor gejala hidung total (SGHT) pada penderita RA. Metode: Penelitian dilaksanakan pada bulan Juli hingga Desember 2016 di Poli Telinga Hidung Tenggorok – Bedah Kepala Leher Rumah Sakit Dr. Soetomo Surabaya. Uji klinis acak terkontrol pada 2 kelompok dengan desain control group in clinical trial. Pengambilan sampel dilakukan secara consecutive sampling. Uji korelasi yang digunakan adalah uji t berpasangan dan uji Wilcoxon. Hasil: Didapatkan sampel 42 penderita, yaitu 21 penderita pada kelompok loratadin, serta 21 penderita pada kelompok loratadin dan cuci hidung salin hipertonik. Didapatkan rerata penurunan transpor mukosiliar kelompok loratadin dan cuci hidung salin hipertonik lebih bermakna daripada kelompok loratadin (p=0,001). Penurunan transpor mukosiliar kelompok loratadin didapatkan rerata -2,30 (SD=2,77), kelompok loratadin dan cuci hidung salin hipertonik didapatkan rerata -6,27 (SD=3,91). Penurunan SGHT kelompok loratadin didapatkan rerata -2,48 (SD=1,72), sedangkan kelompok loratadin dan cuci hidung salin hipertonik didapatkan rerata -4,3 (SD=1,20). Kesimpulan: Penambahan cuci hidung salin hipertonik pada terapi loratadin lebih efektif dibandingkan terapi tunggal loratadin dalam menurunkan transpor mukosiliar dan SGHT pada penderita RA. Kata kunci: Loratadin, cuci hidung salin hipertonik, transpor mukosiliar, skor gejala hidung total, rinitis alergi ABSTRACT Background: Allergic rhinitis (AR) is a nasal mucous membrane inflamatory which mediated by Imunoglobulin E (IgE) after allergen exposure in nasal mucosa. Purpose: To identify the effectiveness of nasal hypertonic saline irrigation on reduction of mucociliary transport time (MCTT) and total nasal symptom score (TNSS) in AR patients. Methods: The was conducted from July until December 2016 in Oto Rhino Laryngology - Head and Neck Surgery of Dr. Soetomo Hospital Surabaya. The study was randomized controlled clinical trials on two groups, with the control group in clinical trial design. Paired t and Wilcoxon test was used as the correlation test. Results: There was 42 patients, 21 patients in loratadine group, and 21 patients in loratadine with hypertonic nasal saline group. The average of mucociliary transport time decrease of loratadine with hypertonic nasal saline group was more significant than loratadine group (p=0.001). The mean of decreasing mucociliary transport time in loratadine group was -2.30 (SD=2.77) and loratadine with hypertonic nasal saline group was -6.27 (SD=3.91). The mean of decreasing TNSS in loratadin group was -2.48 (SD=1.72), and loratadin with hypertonic nasal saline group was -4.3 (SD=1.20). Conclusions: The addition of hypertonic nasal saline in loratadine was more effective, compared to monotherapy of loratadine in decreasing mucociliary transport time and TNSS in patient with AR. Keywords: Loratadine, hypertonic nasal saline, mucociliary transport, total nasal symptom score, allergic rhinitis

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Futura study: evaluation of efficacy and safety of rupatadine fumarate in the treatment of persistent allergic rhinitis

Brazilian Journal of Otorhinolaryngology ◽

10.1590/s1808-86942009000500011 ◽

2009 ◽

Vol 75 (5) ◽

pp. 673-679 ◽

Cited By ~ 4

Author(s):

Olavo de Godoy Mion ◽

Regis A. Campos ◽

Martti Antila ◽

Priscila Bogar Rapoport ◽

Nelson Rosario ◽

...

Keyword(s):

Allergic Rhinitis ◽

Efficacy And Safety ◽

Persistent Allergic Rhinitis ◽

Study Evaluation

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Cost-effectiveness of allergic rhinitis treatment: An exploratory study

SAGE Open Medicine ◽

10.1177/2050312118794588 ◽

2018 ◽

Vol 6 ◽

pp. 205031211879458

Author(s):

Jan Titulaer ◽

Habibollah Arefian ◽

Michael Hartmann ◽

Mustafa Z Younis ◽

Orlando Guntinas-Lichius

Keyword(s):

Allergic Rhinitis ◽

Cost Effectiveness ◽

Side Effects ◽

Symptom Score ◽

Treatment Options ◽

Local Therapy ◽

Cost Effective ◽

Subcutaneous Immunotherapy ◽

Control Group ◽

Placebo Control

Allergic rhinitis is serious public health problems and one of the most common chronic diseases worldwide. We aimed to assess the cost-effectiveness of clinically relevant treatment options for allergic rhinitis using evidence-based literature. In addition, we aimed to develop recommendations for allergic rhinitis treatment based on health economic facts. We searched MEDLINE via PubMed from 2009 to 2014 to identify all therapeutic options described in the current literature and selected randomized controlled trials that used a symptom score, had at least one placebo control group and used adult patients. We analyzed the side effects and the number of cases in which treatment was discontinued for each treatment option. Local antihistamines were the most cost-effective local therapy and are recommended due to the low number of complications. Regarding systemic therapies, although the use of oral steroids is indeed significantly cost-effective, this treatment was found to be associated with strong side effects. Sublingual immunotherapy was identified as the most cost-effective immunotherapy and exhibits a good side-effect profile. Overall, local therapy with antihistamines was found to be the most cost-effective option of all therapies. This study showed that there are only minor differences between sublingual and subcutaneous immunotherapy. Based on our results, we recommend the use of an international, uniform nasal symptom score to facilitate the comparison of clinical trials on allergic rhinitis in the future.

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Ear Acupressure for Allergic Rhinitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2021/6699749 ◽

2021 ◽

Vol 2021 ◽

pp. 1-20

Author(s):

Juan Zhong ◽

Shuqin Liu ◽

Dan Lai ◽

Tao Lu ◽

Yifeng Shen ◽

...

Keyword(s):

Systematic Review ◽

Allergic Rhinitis ◽

Randomized Controlled Trials ◽

Symptom Score ◽

Latin American ◽

Cochrane Library ◽

Control Group ◽

Controlled Trials ◽

Cochrane Central Register ◽

Randomized Controlled

Background. The treatment effects and safety of ear acupressure (EAP) for patients with allergic rhinitis (AR) have yet to be clarified. Objective. To evaluate the effects and safety of EAP in AR patients. Design. Systematic review of published studies. Methods. A total of 24 English and Chinese databases (PubMed, EMBASE (Excerpta Medical Database), Cochrane Central Register of Controlled Trials, CINAHL, Informit, ScienceDirect, LILACS (Latin American and Caribbean Health Sciences), ProQuest, AMED, Blackwell Synergy, PsycINFO, Panteleimon, AcuBriefs, KoreaMed, IndMed, Ingenta, mRCT, ISI Web of Knowledge, ERIC, VIP Information (http://www.cqvip.com), China National Knowledge Infrastructure (http://www.cnki.net), Cochrane Library, Chinese Cochrane Centre Controlled Trials Register Platform, and Wanfang Chinese Digital Periodical and Conference Database) were searched from their respective inceptions to August 2020 to collect randomized controlled trials of ear acupressure for allergic rhinitis. We performed literature inclusion, data extraction, and trial quality evaluations. Methodological quality was assessed according to the Cochrane Handbook. Revman5.3 was used for all analyses. Results. A total of 203 trials were identified and eleven studies involved 1094 participants aged 3–70 years. EAP was better than control group interventions in terms of effectiveness (risk ratio (RR): 0.51; 95% confidence interval (CI): 0.36–0.70; P < 0.0001 ). EAP was superior to sham EAP in terms of improvement of the total nasal symptom score (RR: −0.50; 95% CI: −0.96–0.05; P = 0.03), sneezing score (RR: −0.36; 95% CI: −0.59–0.12; P = 0.003), global QoL score (RR: 0.42; 95% CI: 0.04–0.08; P = 0.03), and eye symptom score (RR: −0.36; 95% CI: −0.67–0.05; P = 0.02). Conclusions. Despite the positive results, it is premature to confirm the efficacy of EAP for treating AR. More high-quality studies are needed to confirm safety and efficacy.

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Transcutaneous electrical acupoint stimulation for high-normal blood pressure: study protocol for a randomized controlled pilot trial

10.21203/rs.2.24687/v1 ◽

2020 ◽

Author(s):

Yu Wang ◽

Guang-Xia Shi ◽

Zhong-Xue Tian ◽

Jun-Hong Liu ◽

You-Sheng Qi ◽

...

Keyword(s):

Blood Pressure ◽

Clinical Trial ◽

Lifestyle Modification ◽

Intervention Group ◽

Normal Blood ◽

Control Group ◽

Efficacy And Safety ◽

Normal Blood Pressure ◽

Change In Mean ◽

Acupoint Stimulation

Abstract Background: High-normal blood pressure (BP) is associated with increased all-cause, cardiovascular mortality and frequently progresses to hypertension. Transcutaneous electrical acupoint stimulation (TEAS) might be a non-pharmaceutical therapy option to control BP. This trial aims to determine the efficacy and safety of TEAS combined with lifestyle modification for high-normal BP. Methods/design: This prospective, randomized and parallel clinical trial will be conducted in a community service center in China. Sixty participants with high-normal BP will be randomly allocated to receive TEAS plus lifestyle modification (intervention group) or lifestyle modification alone (control group) in a 1:1 ratio. In addition to lifestyle modification, the intervention group will receive TEAS at four acupoints for 30 minutes, 4 times weekly for 12 weeks for a total of 48 sessions at home. The control group will receive same lifestyle modification but no TEAS. The primary outcome will be the change in mean systolic blood pressure at 12-week from the baseline measurement. Secondary outcomes include the change of mean diastolic blood pressure, proportion of subjects with progression to hypertension, quality of life, physical activity, body mass index and waist circumference. Adverse events during the trial will be monitored. Discussion: This trial will explore the feasibility and provide potential evidence for the efficacy and safety of TEAS plus lifestyle modification for high-normal BP. The results of this study will be published in a peer-reviewed journal. Trial registration: Chinese Clinical Trial Registry, ChiCTR1900024982. Registered on August 6, 2019.

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Evaluation of the efficacy and safety of favipiravir and interferon compared to lopinavir/ritonavir and interferon in moderately ill patients with COVID-19: a structured summary of a study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-020-04747-8 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Mehdi Hassaniazad ◽

Ali Bazram ◽

Soheil Hassanipour ◽

Mohammad Fathalipour

Keyword(s):

Interferon Beta ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

List Type ◽

Peptic Ulcers ◽

Efficacy And Safety ◽

Open Label ◽

Full Protocol ◽

Bandar Abbas

Abstract Objectives We will evaluate the efficacy and safety of favipiravir and interferon beta-1a compared to lopinavir/ritonavir and interferon beta-1a in patients with confirmed COVID-19, who are moderately ill. Trial design This is a phase 3, single-center, randomized, open-label, controlled trial with a parallel-group design carried out at Shahid Mohammadi Hospital, Bandar Abbas, Iran. Participants All patients with age ≥ 20 years admitted at the Severe Acute Respiratory Syndrome Departments of the Shahid Mohammadi Hospital, Bandar Abbas, Iran, will be screened for the following criteria. Inclusion criteria: Confirmed diagnosis of infection with SARS-CoV-2 using polymerase chain reaction and/or antibody tests. Moderate COVID-19 pneumonia (via computed tomography and/or X-ray imaging), requiring hospitalization. Hospitalized ≤ 48 h. Signing informed consent and willingness of the participant to accept randomization to any assigned treatment arm. Exclusion criteria: Underlying conditions, including chronic hepatitis, cirrhosis, cholestatic liver diseases, cholecystitis, peptic ulcers, acute and chronic renal failure, and peptic ulcers. Severe and critical COVID-19 pneumonia. History of allergy to favipiravir, lopinavir/ritonavir, and interferon beta-1a. Pregnancy and breastfeeding. Intervention and comparator Intervention group: favipiravir (Zhejiang Hisun, China) with interferon beta-1a (CinnaGen, Iran). This group will receive 1600 mg favipiravir twice a day for the first day and 600 mg twice a day for the following 4 days with five doses of 44 mcg interferon beta-1a every other day. Control group: lopinavir/ritonavir (Heterd Company, India) with interferon beta-1a (CinnaGen, Iran). This group will receive 200/50 mg lopinavir/ritonavir twice a day for 7 days with five doses of 44 mcg interferon beta-1a every other day. Other supportive and routine care will be the same in both groups. Main outcomes The primary outcome of the trial is the viral load of SARS-CoV-2 in the nasopharyngeal samples assessed by RT-PCR after 7 days of randomization as well as clinical improvement of fever and O2 saturation within 7 days of randomization. The secondary outcomes are the length of hospital stay and the incidence of serious adverse drug reactions within 7 days of randomization. Randomization Eligible patients will be allocated to one of the study arms using block randomization in a 1:1 ratio (each block consists of 10 patients). A web-based system will be used to generate random numbers for the allocation sequence. Each number relates to one of the study arms. Blinding (masking) This is an open-label trial without blinding and placebo control. Numbers to be randomized (sample size) A total of 60 patients will be randomized into two groups (30 patients in the intervention group and 30 patients in the control group). Trial status The trial protocol is version 1.0, 22 July 2020. Recruitment began on 25 July 2020 and is anticipated to be completed by 25 September 2020. Trial registration Iranian Registry of Clinical Trials (IRCT) IRCT20200506047323N3. Registered on 22 July 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting the dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.

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